Hers is healthcare
that feels like self-care
Hers Weight Loss custom medication kits are prescribed based on what your provider determines is medically appropriate and necessary for you. This may include prescribing generic drug products, and/or compounded products if appropriate and necessary. Compounded drug products are not approved by the FDA and are not evaluated for safety, efficacy, or quality.
*Based on studies of topical and oral minoxidil. Hair Blends are compounded products and have not been approved by the FDA. The FDA does not verfiy the safety or effectiveness of compounded drugs. Prescription products require an online consultation with a licensed provider who will determine if a prescription is appropriate.
*Prescription products available only if prescribed by the healthcare provider after an online consultation.
HERS IN THE NEWS
From the grid
Follow us @hers
@dorapinajoffroy x Rapid Repair Hair Mask
@heytheredolapo x Hers Acne Rx
@megan_jones556 x Hers SPF
@allynfoxx x Hers Multivitamin
Important Safety Information
What is the most important information that I should know about Spironolactone for the treatment of female pattern hair loss (androgenic alopecia):
- Spironolactone is FDA-approved for the treatment of:
- Heart failure
- Hypertension
- Primary hyperaldosteronism
- Edema
- Although spironolactone is not FDA-approved for the treatment of female pattern hair loss, it is often used in dermatologic healthcare for this reason.
- Spironolactone is not used for the treatment of hair loss in men due to side effects (e.g., enlargement of breast tissue) related to its anti-androgenic properties.
- Through the Hers platform, spironolactone is only available to premenopausal women, born female, between the ages of 18-43.
- If you have the potential to become pregnant, you must be on a reliable form of birth control while taking spironolactone due to the risk of birth defects associated with spironolactone. Please see below for more information about this.
Are there any dietary restrictions that I should follow while taking spironolactone?
While taking spironolactone, excessive potassium intake should be avoided. This includes avoiding potassium-containing supplements in addition to salt substitutes that contain potassium. Coconut water contains high amounts of potassium and should be avoided. Most other foods, including bananas, are safe to consume in moderation.
Drinking alcohol may increase certain spironolactone side effects, such as headache or dizziness.
Do not use spironolactone for the treatment of your female pattern hair loss if you:
- Are allergic or hypersensitive to spironolactone or any component of spironolactone’s formulation
Active ingredient:
spironolactone
spironolactone
Inactive Ingredients:
lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinized starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide, iron oxide yellow, iron oxide red
lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinized starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide, iron oxide yellow, iron oxide red
- Are currently taking eplerenone
- Have hyperkalemia
- Have Addison’s disease
- Are pregnant or breastfeeding or are planning to become pregnant
If any of the following apply to you, please speak with a healthcare provider in-person about seeking treatment for your female pattern hair loss:
- Younger than 18 years of age
- You are taking any of the following medications:
- Cholestyramine
- Daily use of acetylsalicylic acid (aspirin) or NSAIDS (e.g., ibuprofen, advil, aleve, naproxen).
- Potassium supplements
- Drugs that increase serum potassium levels (e.g., ACE-inhibitors, angiotensin-receptor blockers, Heparin or low molecular weight heparin)
- Lithium
- Digoxin
- You have any of the following conditions:
- Kidney or liver disease
- Electrolyte imbalances
- Heart disease
- Gout
- Adrenal gland disorder
- Irregular menstrual periods that have not been evaluated by a healthcare provider in-person
- Recent onset of excessive hair growth on the face or body, enlargement of the clitoris, and/or deepening of the voice
These are some of the more common side effects of spironolactone:
- Headache, dizziness, drowsiness, confusion
- Nausea, vomiting, diarrhea
- Abdominal pain
- Irregular menstrual periods
- Breast tenderness/enlargement
- Decreased libido
Contact your healthcare provider right away if you experience any of these side effects:
Hyperkalemia (elevated potassium level in your blood) is a reported serious side effect of spironolactone. Hyperkalemia is rarely seen in young, healthy individuals under 45 without underlying kidney or heart disease. Contact your healthcare provider right away if you experience any of the following symptoms of hyperkalemia:
- Confusion
- Fatigue
- Muscle pain or weakness
- Difficulty with breathing
- Irregular heartbeat
- Nausea
- Tingling or numbness in the arms, hands, legs, or feet
These are not all of the possible side effects of spironolactone. For more information, ask your healthcare provider or pharmacist.
Contract your healthcare provider for medical advice about side effects. You can message a healthcare provider through your Hers account if you have any questions about your treatment, including any side effects you may be experiencing. You may report side effects to FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.
If I am sexually active, is it important to use an effective form of contraception while taking spironolactone?
Yes, spironolactone can potentially cause birth defects in a developing fetus (e.g., feminization of a male fetus). If you are concerned that your birth control method was ineffective or failed, over-the-counter emergency contraception is available but must be taken within 72 hours (3 days) following the sexual act. Prescription emergency contraception (ella®) is also available through a healthcare provider and must be taken within 5 days following the sexual act.
Oral contraceptive pills are often prescribed with spironolactone as a form of birth control and to help maintain regular menstrual periods while preventing side effects, such as breast tenderness.
If you become pregnant while taking spironolactone, you should immediately stop taking spironolactone and inform a medical professional.
Important Safety Information
Through the Hers platform, topical finasteride + minoxidil spray is only available to women aged 43 and over, who are on a reliable form of birth control.
Read this patient information before you start using this medication and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Topical finasteride + minoxidil spray is a prescription medication used for the treatment of female pattern hair loss (androgenetic alopecia).
Unlike oral finasteride (which is FDA-approved only for use in men), topical finasteride + minoxidil spray is a compounded product and has not been approved by the FDA. It is only available if prescribed after an online consultation with a medical provider through the Hers platform.
The use of topical finasteride to treat hair loss has not been as comprehensively studied as oral finasteride. While research has shown that serum DHT levels decrease while using topical finasteride, the systemic side effects (e.g., sexual dysfunction) typically associated with oral finasteride were not reported in the studies of topical finasteride.
Do not use other topical minoxidil or topical finasteride products while you are using this topical finasteride 0.3% + minoxidil 6% spray.
Do not allow individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, or children handle this medication. Do not allow any of these individuals to come into contact with the treatment site (your scalp) after the medication has been applied. If they do, they should immediately clean the site of contact on their skin with soap and water.
What should I tell my healthcare provider before using topical finasteride + minoxidil?
- If you are pregnant, planning to become pregnant, or are breastfeeding
- Topical finasteride + minoxidil spray should not be used or handled by individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, or individuals under the age of 18.
- If you have any other medical conditions
- If you have ever had a hypersensitivity or allergic reaction to topical minoxidil or topical finasteride + minoxidil
- All of the medications that you are currently taking, including prescription and nonprescription medications, vitamins, and herbal supplements.
- Know the medications you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.
Who should not use topical finasteride + minoxidil?
- Do not use topical finasteride + minoxidil if you:
- are currently taking oral finasteride for hair loss or for treatment of an enlarged prostate (Propecia®, Proscar®). Oral finasteride and topical finasteride + minoxidil spray cannot be used at the same time
- are currently taking other medications in the same class as finasteride (5-alpha reductase inhibitors: e.g., dutasteride, Avodart®, Jalyn®)
- are pregnant, trying to get pregnant, or may become pregnant
- due to the possibility of absorption of finasteride and the subsequent potential risk to a male fetus
- are breastfeeding
- are allergic to any of the ingredients of topical finasteride + minoxidil
- have a history of breast cancer, uterine, cervical or ovarian cancer in the last 5 years
- are younger than 18 years of age
What are the possible side effects of topical finasteride + minoxidil spray?
The most common side effects of topical finasteride + minoxidil spray typically occur at the site of medication application (scalp). These side effects include:
- Itching
- Redness
- Irritation
- Burning sensation
- Contact dermatitis
- Dry and flaky scalp
If you develop any of the following side effects, please stop using this topical medication and contact your healthcare provider right away:
- Chest pain
- Rapid heart beat
- Faintness or dizziness
- Sudden and unexplained weight gain
- Swelling of hands or feet
- Breast tenderness/enlargement
- Unwanted facial hair growth
- Sexual dysfunction (e.g., low libido, erectile dysfunction, decreased volume of ejaculate)
- Symptoms of depression
- No scalp hair regrowth after 6 months of use
- Severe scalp irritation
These are not all of the possible side effects of topical finasteride + minoxidil spray. For more information, ask your healthcare provider or pharmacist.
Contact your healthcare provider for medical advice about side effects. You can message a healthcare provider through your Hers account if you have any questions about your treatment, including any side effects you may be experiencing. You may report side effects to FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.
How do I use the topical finasteride + minoxidil spray?
- Use this medication exactly as your healthcare provider tells you to use it.
- Do not use this medication more than once a day as it will not improve results and can increase the risk of side effects.
- Wash your hands with soap immediately after applying this medication to your scalp.
What should I do if this medication gets on my face?
There is the potential for hair growth to occur on any skin that this medication comes into contact with after repeated use. For this reason, only apply the topical finasteride + minoxidil spray to the scalp, and carefully blot any excess to avoid it running onto your face. If it does get on your face, clean off the medication with gentle soap and water.
How should I store the topical finasteride + minoxidil spray?
- Store this medication at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
- Keep this medication and all other medications out of the reach of children.
- Individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, and individuals under the age of 18 should not handle this medication
- Discard any unneeded medication
General information about the safe and effective use of the topical finasteride + minoxidil spray:
- Do not use this medication for a condition for which it was not prescribed.
- Do not give this medication to other people, even if they have the same symptoms you have. It may harm them.
- Minoxidil is suspected to be toxic to cats and dogs. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988634/ Please do not allow cats, dogs, or other pets to ingest this medication or to come into contact with the treatment site after the medication has been applied. If these occur, consult your pet's veterinarian.
Important Safety Information
What is the most important information that I should know about oral minoxidil for the treatment of female pattern hair loss (androgenetic alopecia)?
- Oral minoxidil is FDA-approved for the treatment of high blood pressure
- Low-dose oral minoxidil is used by dermatologists off-label to treat female pattern hair loss
- The efficacy and safety of low-dose oral minoxidil to promote hair growth is supported by clinical evidence including clinical trials
Do not use oral minoxidil for the treatment of your female pattern hair loss if you:
- Are allergic to oral minoxidil
- Are pregnant or breastfeeding
If any of the following apply to you, please speak with a healthcare provider in-person about seeking treatment for your female pattern hair loss:
- Younger than 18 years of age
- Have heart, kidney, or liver disease
- Are taking blood pressure medications for hypertension
- Have experienced dizziness or fainting that occurs upon standing after sitting or lying down
- Have experienced sudden onset of increased muscularity, deepening of the voice, enlargement of the clitoris, or excessive hair growth on the face or body
- Have pheochromocytoma
These are some of the more common side effects of oral minoxidil:
- Hypertrichosis, or increased hair growth on the face or body
- Lightheadedness
- Palpitations or tachycardia
- Headaches
- Leg swelling or fluid retention (edema)
- Swelling around the eyes
- Insomnia
- Nausea
If you experience any of the above side effects, contact your provider as you may benefit from a dose adjustment or change in treatment.
Oral minoxidil can cause early hair shedding as beneficial hair cycling is triggered. This is an expected side effect that will improve with continued minoxidil use.
Minoxidil may cause changes to your EKG; tell your doctor prior to an EKG if you are taking oral minoxidil.
Seek emergency medical care if you experience any of these side effects:
- New or worsening chest pain
- Shortness of breath
- Sudden changes to your vision or hearing
- Very severe heartburn
The above symptoms may be signs of a more serious reaction.
These are not all of the possible side effects of oral minoxidil. For more information, ask your healthcare provider or pharmacist.
Contact your healthcare provider for medical advice about side effects. You can message a healthcare provider through your Hers account if you have any questions about your treatment, including any side effects you may be experiencing. You may report side effects to FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.
Important Safety Information
What is the most important information that I should know about oral minoxidil for the treatment of female pattern hair loss (androgenetic alopecia):
- Oral minoxidil is FDA-approved for the treatment of high blood pressure
- Low-dose oral minoxidil is used by dermatologists off-label to treat female pattern hair loss
- The efficacy and safety of low-dose oral minoxidil to promote hair growth is supported by clinical evidence including clinical trials
- This tablet was formulated with dermatologists who have determined a dosage of 2.5 mg as appropriate when combined with oral minoxidil. It is not recommended that you take additional biotin supplements. High doses of biotin (5 mg or higher) may interfere with certain lab tests, including specific tests to aid in heart attack diagnoses.
Do not use oral minoxidil for the treatment of your female pattern hair loss if you:
- Are allergic to oral minoxidil
- Are pregnant or breastfeeding
If any of the following apply to you, please speak with a healthcare provider in-person about seeking treatment for your female pattern hair loss:
- Younger than 18 years of age
- Have heart, kidney or liver disease
- Are taking blood pressure medications for hypertension
- Have experienced dizziness or fainting that occurs upon standing after sitting or lying down
- Have experienced sudden onset of increased muscularity, deepening of the voice, enlargement of the clitoris, or excessive hair growth on the face or body
- Have pheochromocytoma
These are some of the more common side effects of oral minoxidil:
- Hypertrichosis, or increased hair growth on the face or body
- Lightheadedness
- Palpitations or tachycardia
- Headaches
- Leg swelling or fluid retention (edema)
- Swelling around the eyes
- Insomnia
- Nausea
If you experience any of the above side effects, contact your provider as you may benefit from a dose adjustment or change in treatment.
Oral minoxidil can cause early hair shedding as beneficial hair cycling is triggered. This is an expected side effect that will improve with continued minoxidil use.
Seek emergency medical care if you experience any of these side effects:
- New or worsening chest pain
- Shortness of breath
- Sudden changes to your vision or hearing
- Very severe heartburn
The above symptoms may be signs of a more serious reaction.
These are not all of the possible side effects of oral minoxidil. For more information, ask your healthcare provider or pharmacist.
Contact your healthcare provider for medical advice about side effects. You can message a healthcare provider through your Hers account if you have any questions about your treatment, including any side effects you may be experiencing. You may report side effects to FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.
Important Safety Information
What is the most important information that I should know about Spironolactone for the treatment of female pattern hair loss (androgenic alopecia):
- Spironolactone is FDA-approved for the treatment of:
- Heart failure
- Hypertension
- Primary hyperaldosteronism
- Edema
- Although spironolactone is not FDA-approved for the treatment of female pattern hair loss, it is often used in dermatologic healthcare for this reason.
- Spironolactone is not used for the treatment of hair loss in men due to side effects (e.g., enlargement of breast tissue) related to its anti-androgenic properties.
- Through the Hers platform, spironolactone is only available to premenopausal women, born female, between the ages of 18-43.
- If you have the potential to become pregnant, you must be on a reliable form of birth control while taking spironolactone due to the risk of birth defects associated with spironolactone. Please see below for more information about this.
Are there any dietary restrictions that I should follow while taking spironolactone?
While taking spironolactone, excessive potassium intake should be avoided. This includes avoiding potassium-containing supplements in addition to salt substitutes that contain potassium. Coconut water contains high amounts of potassium and should be avoided. Most other foods, including bananas, are safe to consume in moderation.
Drinking alcohol may increase certain spironolactone side effects, such as headache or dizziness.
Do not use spironolactone for the treatment of your female pattern hair loss if you:
- Are allergic or hypersensitive to spironolactone or any component of spironolactone’s formulation
Active ingredient:
spironolactone
spironolactone
Inactive Ingredients:
lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinized starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide, iron oxide yellow, iron oxide red
lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinized starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide, iron oxide yellow, iron oxide red
- Are currently taking eplerenone
- Have hyperkalemia
- Have Addison’s disease
- Are pregnant or breastfeeding or are planning to become pregnant
If any of the following apply to you, please speak with a healthcare provider in-person about seeking treatment for your female pattern hair loss:
- Younger than 18 years of age
- You are taking any of the following medications:
- Cholestyramine
- Daily use of acetylsalicylic acid (aspirin) or NSAIDS (e.g., ibuprofen, advil, aleve, naproxen).
- Potassium supplements
- Drugs that increase serum potassium levels (e.g., ACE-inhibitors, angiotensin-receptor blockers, Heparin or low molecular weight heparin)
- Lithium
- Digoxin
- You have any of the following conditions:
- Kidney or liver disease
- Electrolyte imbalances
- Heart disease
- Gout
- Adrenal gland disorder
- Irregular menstrual periods that have not been evaluated by a healthcare provider in-person
- Recent onset of excessive hair growth on the face or body, enlargement of the clitoris, and/or deepening of the voice
These are some of the more common side effects of spironolactone:
- Headache, dizziness, drowsiness, confusion
- Nausea, vomiting, diarrhea
- Abdominal pain
- Irregular menstrual periods
- Breast tenderness/enlargement
- Decreased libido
Contact your healthcare provider right away if you experience any of these side effects:
Hyperkalemia (elevated potassium level in your blood) is a reported serious side effect of spironolactone. Hyperkalemia is rarely seen in young, healthy individuals under 45 without underlying kidney or heart disease. Contact your healthcare provider right away if you experience any of the following symptoms of hyperkalemia:
- Confusion
- Fatigue
- Muscle pain or weakness
- Difficulty with breathing
- Irregular heartbeat
- Nausea
- Tingling or numbness in the arms, hands, legs, or feet
These are not all of the possible side effects of spironolactone. For more information, ask your healthcare provider or pharmacist.
Contract your healthcare provider for medical advice about side effects. You can message a healthcare provider through your Hers account if you have any questions about your treatment, including any side effects you may be experiencing. You may report side effects to FDA by calling 1-800-FDA-1088 or visiting http://www.fda.gov/MedWatch.
If I am sexually active, is it important to use an effective form of contraception while taking spironolactone?
Yes, spironolactone can potentially cause birth defects in a developing fetus (e.g., feminization of a male fetus). If you are concerned that your birth control method was ineffective or failed, over-the-counter emergency contraception is available but must be taken within 72 hours (3 days) following the sexual act. Prescription emergency contraception (ella®) is also available through a healthcare provider and must be taken within 5 days following the sexual act.
Oral contraceptive pills are often prescribed with spironolactone as a form of birth control and to help maintain regular menstrual periods while preventing side effects, such as breast tenderness.
If you become pregnant while taking spironolactone, you should immediately stop taking spironolactone and inform a medical professional.
Important Safety Information
Do not take Escitalopram if you:
- are allergic to Escitalopram, or any of the ingredients in Escitalopram
- take any medicines called monoamine oxidase inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days
- also take pimozide (Orap) or citalopram (Celexa)
- are drinking alcohol
- are using or abusing recreation drugs or prescription medications
Escitalopram can cause serious side effects. Rarely reported side effects include:
- increased bleeding (gums)
- low sodium blood levels (symptoms may include headache, weakness and difficulty remembering or concentrating)
- teeth grinding
- seizure
- angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye)
- serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death)
Before you take Escitalopram, tell your healthcare provider if you:
- have thoughts of suicide or harming yourself
- have a history of psychiatric or medical problems, including bipolar disorder
- have taken any medication in the past for your condition, whether effective or not
- have suffered adverse or side effects from previous medication therapies
- are receiving any non-medication treatment, such as talk therapy
- drink alcohol or use/abuse recreational or prescription drugs
- are pregnant, plan to become pregnant, or are breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.
Escitalopram may affect the way other medicines work, and other medicines may affect the way Escitalopram works, causing side effects. Especially tell your healthcare provider if you take any of the following:
- aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen)
- warfarin, and other anticoagulants
- any other serotonergic medications, migraine medications (triptans), pain medications, antibiotic linezolid, amphetamines
During treatment with this medication, the side effects of this medication may go away as your body adjusts to the medication. The most common side effects of Escitalopram: headache, nausea, diarrhea, dry mouth, increased sweating, feeling nervous, restless, fatigued, sleepy or having trouble sleeping (insomnia). Sexual side effects, such as problems with orgasm or ejaculatory delay often do not diminish over time.
Escitalopram is a prescription medicine used to treat major depressive disorder (MDD) and generalized anxiety disorder (GAD). (May also be helpful when prescribed “off-label” for obsessive compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder.)
If you miss a dose of Escitalopram, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.
Do not abruptly stop taking Escitalopram even when you feel better. Abruptly stopping can cause withdrawal symptoms including: vomiting, irritability, dizziness, headaches, sensation of tingling skin, or nightmares.
Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.
Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.
If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can follow these simple steps to dispose of most medicines in your trash at home:
- Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
- Place the mixture in a container such as a sealed plastic bag;
- Throw away the container in your trash at home; and
- Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.
Important Safety Information
Do not take Bupropion XL (bupropion hydrochloride) if you:
- are allergic to Bupropion, as contained in bupropion hydrochloride, or any of the ingredients in Bupropion
- take any medicines called monoamine oxidase inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days
- are already taking a medication containing bupropion
- taking tamoxifen
- have a medical history of a seizure disorder, anorexia nervosa, or bulimia nervosa
- drink large amounts of alcohol, use recreational drugs or abuse prescription medications - or suddenly stop substance abuse habits
Bupropion can cause serious side effects. Rarely reported side effects include:
- Confusion
- Fainting
- Seizures
- Inability to concentrate
- Auditory or visual hallucinations
- Paranoia
Before you take Bupropion, tell your healthcare provider if you:
- have thoughts of suicide or harming yourself
- have a history of psychiatric or medical problems, including bipolar disorder
- have taken any medication in the past for your condition, whether effective or not
- have suffered adverse or side effects from previous medication therapies
- are receiving any non-medication treatment, such as talk therapy
- are pregnant, plan to become pregnant, or are breastfeeding
- drink alcohol or use/abuse recreational or prescription drugs
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.
Bupropion may affect the way other medicines work, and other medicines may affect the way Bupropion works, causing side effects. Especially tell your healthcare provider if you take any of the following:
- take any medicines called monoamine oxidase inhibitor (MAOI), or if you have stopped taking and MAOI in the last 14 days
During treatment with this medication, the side effects of this medication may go away as your body adjusts to the medication. The most common side effects of Bupropion: constipation, decrease in appetite, dizziness, increased sweating, stomach pain, trembling, and unusual weight loss.
Bupropion (bupropion hydrochloride) is a prescription medicine used to treat major depressive disorder (MDD), seasonal affective disorder (SAD), and to help people quit smoking (smoking cessation). (May also be helpful when prescribed “off-label” for bipolar disorder, attention deficit hyperactivity disorder (ADHD, and sexual dysfunction due to SSRI antidepressants.)
Swallow the tablet whole. Do not break, crush or chew it.
If you miss a dose of this medicine, for the XL form, do not take an extra tablet to make up for the dose you forgot. Wait and take your next dose at your regular time the next day. Do not double doses.
Do not stop taking bupropion or change your dose without talking with your healthcare provider first.
While depressed mood and lack of interest in activities may need up to 4-6 weeks to improve, disturbances in sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working.
Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.
If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can follow these simple steps to dispose of most medicines in your trash at home:
- Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
- Place the mixture in a container such as a sealed plastic bag;
- Throw away the container in your trash at home; and
- Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.
Important Safety Information
Do not take Sertraline if you:
- are allergic to Sertraline, or any of the ingredients in Sertraline
- take any medicines called monoamine oxidase inhibitor (MAOI), or if you have stopped taking an MAOI within the last 2 weeks
- taking pimozide
- are drinking alcohol
- are using or abusing recreation drugs or prescription medications
Sertraline can cause serious side effects. Rarely reported side effects include:
- low sodium blood levels (symptoms may include headache, weakness and difficulty remembering or concentrating)
- teeth grinding
- angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye)
- serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death)
- seizure
- increased risk of bleeding events when combined with use of aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen), warfarin, and other anticoagulants
Before you take Sertraline, tell your healthcare provider if you:
- have thoughts of suicide or harming yourself
- have a history of psychiatric or medical problems, including bipolar disorder
- have taken any medication in the past for your condition, whether effective or not
- have suffered adverse or side effects from previous medication therapies
- are receiving any non-medication treatment, such as talk therapy
- drink alcohol or use/abuse recreational or prescription drugs
- are pregnant, plan to become pregnant, or are breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.
Sertraline may affect the way other medicines work, and other medicines may affect the way Sertraline works, causing side effects. Especially tell your healthcare provider if you take any of the following:
- any other serotonergic medications, migraine medications (triptans), pain medications, antibiotic linezolid
- aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen), warfarin, and other anticoagulants
- disulfiram due to the alcohol content of the concentrate - if sertraline in liquid form
During treatment with this medication, the side effects of this medication may go away over the first week or two as your body adjusts to the medication. The most common side effects of Sertraline: Headache, nausea, diarrhea, dry mouth, increased sweating, feeling nervous, restless, fatigued, sleepy or having trouble sleeping (insomnia). Sexual side effects, such as problems with orgasm or ejaculatory delay often do not diminish over time.
Sertraline is a prescription medicine used to treat major depressive disorder (MDD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), panic disorder, and social anxiety disorder. (May also be helpful when prescribed “off-label” for binge-eating disorder, bulimia nervosa, and generalized anxiety disorder (GAD).)
If you miss a dose of sertraline, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.
Do not stop taking sertraline, even when you feel better. Abruptly stopping can cause withdrawal symptoms including: irritability, nausea, feeling dizzy, vomiting, nightmares, headache, and/or paresthesias (prickling, tingling sensation on the skin).
Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.
Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
If needed, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.
If you no longer need your medication, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can follow these simple steps to dispose of most medicines in your trash at home:
- Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
- Place the mixture in a container such as a sealed plastic bag;
- Throw away the container in your trash at home; and
- Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.
Important Safety Information
Do not take Paroxetine if you:
- are allergic to Paroxetine, or any of the ingredients in Fluoxetine
- take any medicines called monoamine oxidase inhibitor (MAOI), or if you have stopped taking an MAOI within the last 14 days
- taking thioridazine
- taking tamoxifen
- taking pimozide
- are drinking alcohol
- are using or abusing recreation drugs or prescription medications
Paroxetine can cause serious side effects. Rarely reported side effects include:
- low sodium blood levels (symptoms may include headache, weakness and difficulty remembering or concentrating)
- teeth grinding
- angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye)
- serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death)
- seizure
- increased risk of bleeding events when combined with use of aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen), warfarin, and other anticoagulants
Before you take Paroxetine, tell your healthcare provider if you:
- have thoughts of suicide or harming yourself
- have a history of psychiatric or medical problems, including bipolar disorder
- have taken any medication in the past for your condition, whether effective or not
- have suffered adverse or side effects from previous medication therapies
- are receiving any non-medication treatment, such as talk therapy
- drink alcohol or use/abuse recreational or prescription drugs
- are pregnant, plan to become pregnant, or are breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.
Paroxetine may affect the way other medicines work, and other medicines may affect the way Paroxetine works, causing side effects. Especially tell your healthcare provider if you take any of the following:
- any other serotonergic medications, migraine medications (triptans), pain medications, antibiotic linezolid, amphetamines
- atomoxetine
- antipsychotics (aripiprazole, risperidone)
- warfarin
- cardiac medications (propafenone, metoprolol, propranolol)
- tricyclic antidepressants (desipramine, imipramine)
During treatment with this medication, the side effects of this medication may go away as your body adjusts to the medication. The most common side effects of Paroxetine: Headache, nausea, constipation, diarrhea, dry mouth, increased sweating, and dizziness, feeling nervous, restless, fatigued, sleepy, or having trouble sleeping (insomnia). Sexual side effects, such as problems with orgasm or ejaculatory delay often do not diminish over time.
Paroxetine is a prescription medicine used to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (social phobia), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD).
The controlled release form should be swallowed whole. Do not break, crush or chew it.
If you miss a dose of paroxetine, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.
Do not stop taking paroxetine, even when you feel better. Abruptly stopping can cause withdrawal symptoms including: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances as electric shock sensations, tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, ringing in the ears, and seizures.
Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.
Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.
If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can follow these simple steps to dispose of most medicines in your trash at home:
- Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
- Place the mixture in a container such as a sealed plastic bag;
- Throw away the container in your trash at home; and
- Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.
Important Safety Information
BUPROPION XL (Wellbutrin XL©) is a prescription medicine that is FDA approved to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).
When prescribed off-label Bupropion may help some adults with overweight and obesity lose weight and keep the weight off.
IMPORTANT SAFETY INFORMATION
WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS
Suicidal Thoughts or Actions and Antidepressant Drugs
Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. BUPROPION XL has not been evaluated for use in patients under the age of 18.
Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
Although BUPROPION XL is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking.
Some people have had serious side effects while taking bupropion to help them quit smoking, including:
New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.
Stop taking BUPROPION XL and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take BUPROPION XL. In many people, these symptoms went away after stopping BUPROPION XL, but in some people, symptoms continued after stopping BUPROPION XL. It is important for you to follow-up with your healthcare provider until your symptoms go away.
What Other Important Information Should I Know About BUPROPION XL?
Before taking BUPROPION XL, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion.
What Other Important Information Should I Know About BUPROPION XL?
- Seizures: There is a chance of having a seizure (convulsion, fit) with BUPROPION XL, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking BUPROPION XL unless your healthcare provider has said it is okay to take them. If you have a seizure while taking BUPROPION XL, stop taking the tablets and call your healthcare provider right away.
- High blood pressure (hypertension): Some people get high blood pressure that can be severe while taking BUPROPION XL.
- Manic episodes: Some people may have periods of mania while taking BUPROPION XL. If you have any of the following symptoms of mania, call your healthcare provider:
- greatly increased energy
- severe trouble sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
- excessive happiness or irritability
- talking more or faster than usual
- Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking BUPROPION XL, including delusions (e.g., believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
- Visual problems: Some people are at risk of glaucoma which can present as: eye pain, changes in vision, or swelling and redness around the eye if they take BUPROPION XL. You should see an eye doctor to determine whether you are at risk prior to starting therapy.
- Severe allergic reactions: Some patients have severe allergic reactions to WELLBUTRIN XL. Stop taking BUPROPION XL and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
Do not take BUPROPION XL if you:
- have or had a seizure disorder or epilepsy
- have or had an eating disorder such as anorexia nervosa or bulimia - are taking any other medicines that contain bupropion, including WELLBUTRIN or WELLBUTRIN SR, APLENZIN®, ZYBAN, or FORFIVO XL. Bupropion is the same active ingredient that is in WELLBUTRIN XL
- drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden
- take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
- do not take an MAOI within 2 weeks of stopping BUPROPION XL unless directed to do so by your healthcare provider
- do not start BUPROPION XL if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider
- are allergic to the active ingredient in BUPROPION XL, bupropion, or to any of the inactive ingredients
Although BUPROPION XL is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking. Before taking BUPROPION XL, tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without bupropion. Also, tell your healthcare provider about your other medical conditions, including if you:
- have liver problems, especially cirrhosis of the liver
- have kidney problems
- have, or have had, an eating disorder such as anorexia nervosa or bulimia
- have had a head injury
- have had a seizure (convulsion, fit)
- have a tumor in your nervous system (brain or spine)
- have had a heart attack, heart problems, or high blood pressure
- are a diabetic taking insulin or other medicines to control your blood sugar
- drink alcohol
- abuse prescription medicines or street drugs
- are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take BUPROPION XL during pregnancy, and about registering with the National Pregnancy Registry by calling 1-844-405-6185
- are breastfeeding. BUPROPION XL passes into your milk in small amounts
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using BUPROPION XL.
The most common side effects of BUPROPION XL include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches.
These are not all the side effects of BUPROPION XL.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.
Important Safety Information
METFORMIN XR is a prescription medicine that is FDA approved to treat Type 2 diabetes mellitus when hyperglycemia cannot be managed with diet and exercise alone.
When prescribed off-label METFORMIN XR may help some adults with overweight or obesity lose weight and keep the weight off.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about METFORMIN XR tablets?
Lactic Acidosis. Metformin, the medicine in METFORMIN XR tablets, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.
Stop taking METFORMIN XR tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:
- feel very weak and tired
- have unusual (not normal) muscle pain
- have trouble breathing
- have unusual sleepiness or sleep longer than usual
- have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
- feel cold, especially in your arms and legs
- feel dizzy or lightheaded
- have a slow or irregular heartbeat
You have a higher chance of getting lactic acidosis if you:
- have kidney problems. People whose kidneys are not working properly should not take METFORMIN XR tablets.
- have liver problems.
- have congestive heart failure that requires treatment with medicines.
- drink a lot of alcohol (very often or short-term "binge" drinking).
- get dehydrated (lose a large amount of body fluids). This can happen - if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
- have certain x-ray tests with injectable dyes or contrast agents.
- have surgery.
- have a heart attack, severe infection, or stroke.
- are 80 years of age or older and have not had your kidney function tested.
Do not take METFORMIN XR tablets if you:
- have kidney problems
- are allergic to the metformin in METFORMIN XR tablets or any of the ingredients in METFORMIN XR tablets. See the medication guide for the full list of ingredients.
- are going to get an injection of dye or contrast agents for an x-ray procedure or if you are going to have surgery and not able to eat or drink much. In these situations, METFORMIN XR tablets will need to be stopped for a short time. Talk to your healthcare provider about when you should stop METFORMIN XR tablets and when you should start METFORMIN XR tablets again.
What should I tell my healthcare provider before taking METFORMIN XR tablets?
Before taking METFORMIN XR tablets, tell your healthcare provider if you:
- have type 1 diabetes. METFORMIN XR tablets should not be used to treat people with type 1 diabetes.
- have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). METFORMIN XR tablets should not be used for the treatment of diabetic ketoacidosis.
- have kidney problems.
- have liver problems.
- have heart problems, including congestive heart failure.
- are older than 80 years. If you are over 80 years old you should not take METFORMIN XR tablets unless your kidneys have been checked and they are normal.
- drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
- are taking insulin.
- have any other medical conditions.
- are pregnant or plan to become pregnant. It is not known if metformin will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
- are breast-feeding or plan to breast-feed. It is not known if metformin passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take METFORMIN XR tablets. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
- METFORMIN XR tablets may affect the way other medicines work, and other medicines may affect how METFORMIN XR tablets work.
Common side effects of METFORMIN XR tablets include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your healthcare provider if the side effects bother you a lot, last for more than a few weeks, come back after they've gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.
About 3 out of every 100 people who take METFORMIN XR tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.
METFORMIN XR tablets rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.
Important Safety Information
TOPIRAMATE + VITAMIN B12 is a compounded product and is not FDA-approved. The FDA does not verify the safety or effectiveness of compounded drugs.
TOPIRAMATE (Topamax®) is FDA approved to:
- to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older,
- with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older,
- to prevent migraine headaches in adults and adolescents 12 years and older.
VITAMIN B12 is a dietary supplement utilized in many areas of the body principally for the proper function of your red blood cells, nerve cells, energy levels and mood. Additionally it is used to supplement B12 when other drugs may possibly decrease its level.
TOPIRAMATE + VITAMIN B12 is prescribed off-label and may help some adults with overweight and obesity lose weight and keep the weight off.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TOPIRAMATE + VITAMIN B12?
TOPIRAMATE + VITAMIN B12 may cause eye problems. Serious eye problems include:
- Any sudden decrease in vision with or without eye pain and redness.
- A blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).
These eye problems can lead to permanent loss of vision if not treated.
You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision.
TOPIRAMATE + VITAMIN B12 may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away.
TOPIRAMATE + VITAMIN B12 can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:
- Feel tired
- Not feel hungry (loss of appetite)
- Feel changes in heartbeat
- Have trouble thinking clearly
Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPIRAMATE + VITAMIN B12. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, TOPIRAMATE + VITAMIN B12 may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
| • Thoughts about suicide or dying | • Feeling agitated or restless |
| • Attempts to commit suicide | • Trouble sleeping (insomnia) |
| • New or worse depression | • New or worse irritability |
| • New or worse anxiety | • Acting aggressive, being angry or violent |
| • Panic attacks | • Acting on dangerous impulses |
| • An extreme increase in activity and talking (mania) | • Other unusual changes in behavior or mood |
TOPIRAMATE + VITAMIN B12 may lower bone mineral density. TOPIRAMATE + VITAMIN B12 may decrease the density of bones when used over a long period.
TOPIRAMATE + VITAMIN B12 may have negative effects on growth in children
TOPIRAMATE + VITAMIN B12 may slow height increases and weight gain in children and adolescents when used over a long period
Do not stop TOPIRAMATE + VITAMIN B12 without first talking to a healthcare provider.
- Stopping TOPIRAMATE + VITAMIN B12 suddenly can cause serious problems.
- Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
- If you have epilepsy and you stop taking TOPIRAMATE + VITAMIN B12 suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking TOPIRAMATE + VITAMIN B12 slowly.
- If you miss a single dose of TOPIRAMATE + VITAMIN B12, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of TOPIRAMATE + VITAMIN B12 and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call your healthcare provider for advice.
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
- Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
TOPIRAMATE + VITAMIN B12 can harm your unborn baby.
- If you take TOPIRAMATE + VITAMIN B12 during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
- Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors.
- There may be other medicines to treat your condition that have a lower chance of birth defects.
- All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of TOPIRAMATE + VITAMIN B12. If the decision is made to use TOPIRAMATE + VITAMIN B12, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your doctor about the best kind of birth control to use while you are taking TOPIRAMATE + VITAMIN B12.
- Tell your healthcare provider right away if you become pregnant while taking TOPIRAMATE + VITAMIN B12. You and your healthcare provider should decide if you will continue to take TOPIRAMATE + VITAMIN B12 while you are pregnant.
- If you take TOPIRAMATE + VITAMIN B12 during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have questions about this risk during pregnancy.
- Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if TOPIRAMATE + VITAMIN B12 has caused metabolic acidosis during your pregnancy.
- Pregnancy Registry: If you become pregnant while taking TOPIRAMATE + VITAMIN B12, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of TOPIRAMATE + VITAMIN B12 and other antiepileptic drugs during pregnancy.
Before taking TOPIRAMATE + VITAMIN B12, tell your healthcare provider about all of your medical conditions, including if you:
- Have or have had depression, mood problems, or suicidal thoughts or behavior
- Have kidney problems, have kidney stones, or are getting kidney dialysis
- Have a history of metabolic acidosis (too much acid in the blood)
- Have liver problems
- Have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density)
- Have lung or breathing problems
- Have eye problems, especially glaucoma
- Have diarrhea
- Have a growth problem
- Are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet
- Are having surgery
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed? TOPIRAMATE + VITAMIN B12 passes into breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the TOPIRAMATE + VITAMIN B12 that passes into breast milk can cause serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take TOPIRAMATE + VITAMIN B12.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TOPIRAMATE + VITAMIN B12 and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
- Valproic acid (such as Depakene® or Depakote®).
- Any medicines that impair or decrease your thinking, concentration, or muscle coordination.
- Birth control that contains hormones (such as pills, implants, patches or injections). TOPIRAMATE + VITAMIN B12 may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and TOPIRAMATE + VITAMIN B12.
Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
How should I take TOPIRAMATE + VITAMIN B12?
- Take TOPIRAMATE + VITAMIN B12 exactly as prescribed.
- Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
- Take TOPIRAMATE + VITAMIN B12 tablets whole. Do not chew the tablets. They may leave a bitter taste.
- TOPIRAMATE + VITAMIN B12 can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking TOPIRAMATE + VITAMIN B12.
- If you take too much TOPIRAMATE + VITAMIN B12, call your healthcare provider right away or go to the nearest emergency room.
- If you miss a single dose of TOPIRAMATE + VITAMIN B12, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of TOPIRAMATE + VITAMIN B12 and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call your healthcare provider for advice.
- Do not stop taking TOPIRAMATE + VITAMIN B12 without talking to your healthcare provider. Stopping TOPIRAMATE + VITAMIN B12 suddenly may cause serious problems. If you have epilepsy and you stop taking TOPIRAMATE + VITAMIN B12 suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking TOPIRAMATE + VITAMIN B12 slowly.
- Your healthcare provider may do blood tests while you take TOPIRAMATE + VITAMIN B12.
What should I avoid while taking TOPIRAMATE + VITAMIN B12?
- You should not drink alcohol while taking TOPIRAMATE + VITAMIN B12. TOPIRAMATE + VITAMIN B12 and alcohol can affect each other, causing side effects such as sleepiness and dizziness.
- Do not drive a car or operate machinery until you know how TOPIRAMATE + VITAMIN B12 affects you. TOPIRAMATE + VITAMIN B12 can slow your thinking and motor skills, and may affect vision.
Even when taking TOPIRAMATE + VITAMIN B12 or other antiepileptic medicines, some people with epilepsy will continue to have unpredictable seizures. Therefore, use caution and talk to your doctor before beginning any activities where loss of consciousness could result in serious danger to you or those around you (including swimming, driving a car, climbing in high places, etc.).
What are the possible side effects of TOPIRAMATE + VITAMIN B12?
TOPIRAMATE + VITAMIN B12 may cause serious side effects including:
See “What is the most important information I should know about TOPIRAMATE + VITAMIN B12?”
High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when TOPIRAMATE + VITAMIN B12 is taken with a medicine called valproic acid (Depakene® or Depakote®).
Effects on thinking and alertness. TOPIRAMATE + VITAMIN B12 may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. TOPIRAMATE + VITAMIN B12 may cause depression or mood problems, tiredness, and sleepiness.
Dizziness or loss of muscle coordination.
Serious skin reactions. TOPIRAMATE + VITAMIN B12 may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). TOPIRAMATE + VITAMIN B12 may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
Kidney stones. Drink plenty of fluids when taking TOPIRAMATE + VITAMIN B12 to decrease your chances of getting kidney stones.
Low body temperature. Taking TOPIRAMATE + VITAMIN B12 when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.
Effects on thinking and alertness. TOPIRAMATE + VITAMIN B12 may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. TOPIRAMATE + VITAMIN B12 may cause depression or mood problems, tiredness, and sleepiness.
Dizziness or loss of muscle coordination.
Serious skin reactions. TOPIRAMATE + VITAMIN B12 may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). TOPIRAMATE + VITAMIN B12 may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
Kidney stones. Drink plenty of fluids when taking TOPIRAMATE + VITAMIN B12 to decrease your chances of getting kidney stones.
Low body temperature. Taking TOPIRAMATE + VITAMIN B12 when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.
Call your healthcare provider right away if you have any of the symptoms above.
The most common side effects of TOPIRAMATE + VITAMIN B12 include:
| • Tingling of the arms and legs (paresthesia) | • Dizziness |
| • Not feeling hungry | • Sleepiness/drowsiness |
| • Nausea | • Slow reactions |
| • A change in the way foods taste | • Difficulty with memory |
| • Diarrhea | • Pain in the abdomen |
| • Weight loss | • Fever |
| • Nervousness | • Abnormal vision |
| • Upper respiratory tract infection | • Decreased feeling or sensitivity, especially in the skin |
| • Speech problems | |
| • Tiredness |
Tell your healthcare provider about any side effect that bothers you or that does not go away. You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
These are not all the possible side effects of TOPAMAX
Important Safety Information
NALTREXONE + VITAMIN B12 is a compounded product and is not FDA-approved. The FDA does not verify the safety or effectiveness of compounded drugs
NALTREXONE is a prescription medication that is FDA approved to:
treat alcohol dependence
prevent relapse to opioid dependence, after opioid detoxification.
VITAMIN B12 is a dietary supplement utilized in many areas of the body principally for the proper function of your red blood cells, nerve cells, energy levels and mood. Additionally it is used to supplement B12 when other drugs may possibly decrease its level.
NALTREXONE + VITAMIN B12 is a prescription medicine that is prescribed off-label and may help some adults with overweight and obesity lose weight and keep the weight off.
IMPORTANT SAFETY INFORMATION
NALTREXONE + VITAMIN B12 can cause serious side effects, including:
- Risk of opioid overdose. You can accidentally overdose in two ways.
- NALTREXONE + VITAMIN B12 blocks the effects of opioids, such as heroin or opioid pain medicines, examples include, but are not limited to; morphine (MS Contin), hydrocodone (Vicodin), oxycodone (Oxycontin), hydromorphone (Percocet), codeine, or tramadol. Do not try to overcome this blocking effect by taking large amounts of opioids—this can lead to serious injury, coma, or death.
- After you receive a dose of NALTREXONE + VITAMIN B12, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with NALTREXONE + VITAMIN B12 can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
- after you have gone through detoxification
- when your next NALTREXONE + VITAMIN B12 dose is due
- if you miss a dose of NALTREXONE + VITAMIN B12
- after you stop NALTREXONE + VITAMIN B12 treatment
- Tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
Talk to your healthcare provider about naloxone, a medicine that is available to patients for the emergency treatment of an opioid overdose.
Call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.
- Sudden opioid withdrawal. To avoid sudden opioid withdrawal, you must stop taking any type of opioid, including street drugs; prescription pain medicines; cough, cold, or diarrhea medicines that contain opioids; or opioid-dependence treatments, including buprenorphine or methadone, for at least 7 to 14 days before starting NALTREXONE + VITAMIN B12. Sudden opioid withdrawal can be severe and may require hospitalization.
- Liver damage or hepatitis. NALTREXONE + VITAMIN B12 can cause liver damage or hepatitis. Tell your healthcare provider if you have any of these symptoms during treatment with NALTREXONE + VITAMIN B12:
- stomach area pain lasting more than a few days
- dark urine
- yellowing of the whites of your eyes
- tiredness
- Your healthcare provider may need to stop treating you with NALTREXONE + VITAMIN B12 if you get signs or symptoms of a serious liver problem.
You must stop taking opioids before you start taking NALTREXONE + VITAMIN B12. It is not known if NALTREXONE + VITAMIN B12 is safe and effective in children.
Who should not take NALTREXONE + VITAMIN B12?
Do not take NALTREXONE + VITAMIN B12 if you:
- are using or have a physical dependence on opioid-containing medicines, such as but not limited to, morphine (MS Contin), hydrocodone (Vicodin), oxycodone (Oxycontin), hydromorphone (Percocet), codeine, or tramadol. or opioid street drugs, such as heroin.
- are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid containing medicines or opioid street drugs regularly and then stop. Symptoms of opioid withdrawal may include: anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goosebumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps.
- are allergic to NALTREXONE + VITAMIN B12 or any of the inactive ingredients in NALTREXONE + VITAMIN B12. See the medication guide for the full list of ingredients.
What should I tell my healthcare provider before taking NALTREXONE + VITAMIN B12?
Before you take NALTREXONE + VITAMIN B12, tell your healthcare provider if you:
- have liver problems, use or abuse street (illegal) drugs, have hemophilia or other bleeding problems, have kidney problems, or have any other medical conditions.
- are pregnant or plan to become pregnant. It is not known if NALTREXONE + VITAMIN B12 will harm your unborn baby. are breastfeeding. NALTREXONE + VITAMIN B12 passes into breast milk. Talk - to your healthcare provider about whether you will breastfeed or take NALTREXONE + VITAMIN B12. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any opioid-containing medicines for pain, cough or colds, or diarrhea.
What are other possible serious side effects of NALTREXONE + VITAMIN B12?
NALTREXONE + VITAMIN B12 can cause serious side effects, including:
Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and people closest to you that you are taking NALTREXONE + VITAMIN B12.
Pneumonia. Some people receiving NALTREXONE + VITAMIN B12 treatment have had a type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital.
Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of NALTREXONE + VITAMIN B12. Tell your healthcare provider or get medical help right away if you have any of these symptoms:
Pneumonia. Some people receiving NALTREXONE + VITAMIN B12 treatment have had a type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital.
Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of NALTREXONE + VITAMIN B12. Tell your healthcare provider or get medical help right away if you have any of these symptoms:
- skin rash
- swelling of your face, eyes, mouth, or tongue
- trouble breathing or wheezing
- chest pain
- feeling dizzy or faint
Common side effects of NALTREXONE + VITAMIN B12 may include:
- nausea
- sleepiness
- headache
- dizziness
- vomiting
- decreased appetite
- painful joints
- muscle cramps
- cold symptoms
- trouble sleeping
- toothache
These are not all the side effects of NALTREXONE + VITAMIN B12. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. This is only a summary of the most important information about NALTREXONE + VITAMIN B12.
Need more information?
Ask your healthcare provider or pharmacist.