Meridia

Meridia is part of the drug class:

• Centrally acting antiobesity products

Concomitant Cardiovascular Disease

Due to an increased risk of heart attack and stroke in patients with cardiovascular disease, Meridia should not be used in patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Blood Pressure and Pulse

Meridia SUBSTANTIALLY INCREASES BLOOD PRESSURE AND/OR PULSE RATE IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE AND PULSE RATE IS REQUIRED WHEN PRESCRIBING Meridia.

In placebo-controlled obesity studies, sibutramine 5 to 20 mg once daily was associated with mean increases in systolic and diastolic blood pressure of approximately 1 to 3 mm Hg relative to placebo, and with mean increases in pulse rate relative to placebo of approximately 4 to 5 beats per minute. Larger increases were seen in some patients, particularly when therapy with sibutramine was initiated at the higher doses (see table below). In premarketing placebo-controlled obesity studies, 0.4% of patients treated with sibutramine were discontinued for hypertension (SBP ≥160 mm Hg or DBP ≥ 95 mm Hg), compared with 0.4% in the placebo group, and 0.4% of patients treated with sibutramine were discontinued for tachycardia (pulse rate ≥ 100 bpm), compared with 0.1% in the placebo group. Blood pressure and pulse should be measured prior to starting therapy with Meridia and should be monitored at regular intervals thereafter. For patients who experience a sustained increase in blood pressure or pulse rate while receiving Meridia, either dose reduction or discontinuation should be considered. Meridia should be given with caution to those patients with a history of hypertension (see DOSAGE AND ADMINISTRATION), and should not be given to patients with uncontrolled or poorly controlled hypertension.

Potential Interaction With Monoamine Oxidase Inhibitors

Meridia is a norepinephrine, serotonin and dopamine reuptake inhibitor and should not be used concomitantly with MAOIs (see PRECAUTIONS, Drug Interactions subsection). There should be at least a 2-week interval after stopping MAOIs before commencing treatment with Meridia. Similarly, there should be at least a 2-week interval after stopping Meridia before starting treatment with MAOIs.

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions

The development of a potentially life-threatening serotonin syndrome, or Neuroleptic Malignant Syndrome (NMS)-like reactions, has been reported with SNRIs and SSRIs alone, including Meridia treatment, but particularly with concomitant use of serotonergic drugs (including triptans), with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms [e.g., nausea, vomiting, diarrhea] (see PRECAUTIONS, Drug Interactions). Serotonin syndrome, in its most severe form, can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.

Glaucoma

Because Meridia can cause mydriasis, it should be used with caution in patients with narrow angle glaucoma.

Miscellaneous

Organic causes of obesity (e.g., untreated hypothyroidism) should be excluded before prescribing Meridia.

In placebo-controlled studies, 9% of patients treated with sibutramine (n = 2068) and 7% of patients treated with placebo (n = 884) withdrew for adverse events.

In placebo-controlled studies, the most common events were dry mouth, anorexia, insomnia, constipation and headache. Adverse events in these studies occurring in ≥ 1% of sibutramine treated patients and more frequently than in the placebo group are shown in the following table.

The following additional adverse events were reported in ≥ 1% of all patients who received sibutramine in controlled and uncontrolled premarketing studies.

Body as a Whole

fever.

Digestive System

diarrhea, flatulence, gastroenteritis, tooth disorder.

Metabolic and Nutritional

peripheral edema.

Musculoskeletal System

arthritis.

Nervous System

agitation, leg cramps, hypertonia, thinking abnormal.

Respiratory System

bronchitis, dyspnea.

Skin and Appendages

pruritus.

Special Senses

amblyopia.

Urogenital System

menstrual disorders.

Other Adverse Events

Seizures

Convulsions were reported as an adverse event in three of 2068 (0.1%) sibutramine treated patients and in none of 884 placebo-treated patients in placebo-controlled premarketing obesity studies. Two of the three patients with seizures had potentially predisposing factors (one had a prior history of epilepsy; one had a subsequent diagnosis of brain tumor). The incidence in all subjects who received sibutramine (three of 4,588 subjects) was less than 0.1%.

Ecchymosis/Bleeding Disorders

Ecchymosis (bruising) was observed in 0.7% of sibutramine treated patients and in 0.2% of placebo-treated patients in premarketing placebo-controlled obesity studies. One patient had prolonged bleeding of a small amount which occurred during minor facial surgery. Sibutramine may have an effect on platelet function due to its effect on serotonin uptake.

Interstitial Nephritis

Acute interstitial nephritis (confirmed by biopsy) was reported in one obese patient receiving sibutramine during premarketing studies. After discontinuation of the medication, dialysis and oral corticosteroids were administered; renal function normalized. The patient made a full recovery.

Altered Laboratory Findings

Abnormal liver function tests, including increases in AST, ALT, GGT, LDH, alkaline phosphatase and bilirubin, were reported as adverse events in 1.6% of sibutramine-treated obese patients in placebo-controlled trials compared with 0.8% of placebo patients. In these studies, potentially clinically significant values (total bilirubin ≥ 2 mg/dL; ALT, AST, GGT, LDH, or alkaline phosphatase ≥ 3 × upper limit of normal) occurred in 0% (alkaline phosphatase) to 0.6% (ALT) of the sibutramine treated patients and in none of the placebo-treated patients. Abnormal values tended to be sporadic, often diminished with continued treatment, and did not show a clear dose-response relationship.

Postmarketing Reports

Voluntary reports of adverse events temporally associated with the use of sibutramine are listed below. It is important to emphasize that although these events occurred during treatment with sibutramine, they may have no causal relationship with the drug. Obesity itself, concurrent disease states/risk factors, or weight reduction may be associated with an increased risk for some of these events.

Cases of depression, psychosis, mania, suicidal ideation and suicide have been reported rarely in patients on sibutramine treatment. However, a relationship has not been established between these events and the use of sibutramine. If any of these events should occur during treatment with sibutramine, discontinuation should be considered.

Allergic hypersensitivity reactions ranging from mild skin eruptions and urticaria to angioedema and anaphylaxis have been reported (see CONTRAINDICATIONS and PRECAUTIONS-Information For Patients, and other reports of allergic reactions listed below).

Body as a Whole

anaphylactic shock, anaphylactoid reaction, chest pressure, chest tightness, facial edema, limb pain, sudden unexplained death.

Cardiovascular System

angina pectoris, atrial fibrillation, congestive heart failure, heart arrest, heart rate decreased, myocardial infarction, supraventricular tachycardia, syncope, torsade de pointes, vascular headache, ventricular tachycardia, ventricular extrasystoles, ventricular fibrillation.

Digestive System

cholecystitis, cholelithiasis, duodenal ulcer, eructation, gastrointestinal hemorrhage, increased salivation, intestinal obstruction, mouth ulcer, stomach ulcer, tongue edema.

Endocrine System

goiter, hyperthyroidism, hypothyroidism.

Hemic and Lymphatic System

anemia, leukopenia, lymphadenopathy, petechiae, thrombocytopenia.

Metabolic and Nutritional

hyperglycemia, hypoglycemia.

Musculoskeletal System

arthrosis, bursitis.

Nervous System

abnormal dreams, abnormal gait, amnesia, anger, cerebrovascular accident, concentration impaired, confusion, depression aggravated, Gilles de la Tourette’s syndrome, hypesthesia, libido decreased, libido increased, mood changes, nightmares, short term memory loss, speech disorder, transient ischemic attack, tremor, twitch, vertigo.

Respiratory System

epistaxis, nasal congestion, respiratory disorder, yawn.

Skin and Appendages

alopecia, dermatitis, photosensitivity (skin), urticaria.

Special Senses

abnormal vision, blurred vision, dry eye, eye pain, increased intraocular pressure, otitis externa, otitis media, photosensitivity (eyes), tinnitus.

Urogenital System

abnormal ejaculation, hematuria, impotence, increased urinary frequency, micturition difficulty, urinary retention.

Meridia® (mer-ID-dee-uh) (CIV)

(sibutramine hydrochloride monohydrate)

Capsules

Read this Medication Guide before you start taking Meridia and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Meridia?

Meridia can cause serious side effects including a large increase in your blood pressure or heart rate (pulse). Do not take Meridia if your blood pressure is not well controlled. Call your doctor right away if you check your blood pressure and it is higher than normal for you, or if you have symptoms of high blood pressure such as headache, dizziness or blurred vision.

Before you start taking Meridia, your doctor should check your blood pressure and heart rate. Your doctor should continue checking your blood pressure regularly while you are taking Meridia. It is important that you have regular check-ups while you are taking Meridia.

What is Meridia?

Meridia is a prescription medicine used to help overweight or obese people lose weight and keep the weight off. Meridia should be used together with a low calorie diet.

Meridia contains sibutramine, a substance that people can become addicted to. Keep your Meridia in a safe place to protect it from theft. Never give your Meridia to anyone else, because it may cause death or harm them. Selling or giving away this medicine is against the law.

The use of Meridia for more than 2 years has not been studied.

It is not known if Meridia is safe and effective in children younger than 16 years old.

Who should not take Meridia?

Do not take Meridia if you:

• have or have had, heart problems, including:
  • heart attack
  • chest pain
  • heart failure
  • fast or irregular heart beat
  • hardening of your arteries or other blood vessels
  • poor circulation in your legs
• have or have ever had, a stroke or symptoms of a stroke
• uncontrolled high blood pressure (above 145/90)
• are over age 65
• are taking or have taken a type of medicine used to treat depression called a monoamine oxidase inhibitor (MAOI) in the past 2 weeks. Do not take MAOIs for at least 2 weeks before using Meridia. Do not take MAOIs for at least 2 weeks after stopping Meridia. Ask your doctor or pharmacist if you are not sure if any of your medicines are MAOIs.
• have an eating problem called anorexia nervosa or bulimia nervosa.
• are taking certain other weight loss medicines.
• are allergic to sibutramine hydrochloride monohydrate or any other ingredients in Meridia. See the end of this Medication Guide for a complete list of ingredients in Meridia.

Talk to your doctor before taking this medicine if you have any of these conditions.

What should I tell my doctor before taking Meridia?

Before you take Meridia, tell your doctor if you:

• have liver or kidney problems
• have glaucoma
• have or had seizures (convulsions, fits)
• have bleeding problems
• have or had gallstones
• are pregnant or plan to become pregnant. It is not known if Meridia will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. If you can become pregnant, you should use birth control while taking Meridia. Tell your doctor right away if you become pregnant while taking Meridia.
• are breastfeeding or plan to breastfeed. It is not known if Meridia passes into your breast milk. You and your doctor should decide if you will take Meridia or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using Meridia with certain other medicines may affect how Meridia or the other medicines work. Using Meridia with other medicines can cause serious side effects.

Especially tell your doctor if you take:

• a monoamine oxidase inhibitors (MAOIs) medicine. See "Who should not take Meridia?"
• other weight loss medicines
• cough and cold medicines
• migraine headache medicines like sumatriptan (Imitrex, Imitrex Statdose) or dihydroergotamine (D.H.E 45, Migranal)
• medicines to treat depression
• narcotic pain medicines
• lithium (Lithobid)
• tryptophan
• medicines that thin the blood

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine.

How should I take Meridia?

• Take Meridia exactly as your doctor tells you to.
• Take Meridia 1 time a day.
• If you miss a dose of Meridia, just skip it. Do not take an extra dose to make up for missed doses.
• If you take too much Meridia, call your doctor or Poison Control Center right away, or go to the emergency room.
• Your doctor may change your dose if needed.
• Take Meridia with or without food.
• You should see your doctor regularly for check-ups.

What should I avoid while taking Meridia?

• Do not drive, operate heavy machinery or do other dangerous activities until you know how Meridia affects you.
• Do not have more than two standard alcoholic drinks per day while you take Meridia.

What are the possible side effects of Meridia?

Meridia may cause serious side effects, including:

• See “What is the most important information I should know about Meridia?”
• serotonin syndrome. Serotonin syndrome may happen when people take Meridia with certain other medicines that affect a brain chemical called serotonin. Do not take other medicines with Meridia unless your doctor has told you to. Get medical help right away if you have any of the following symptoms:
  • feel weak, restless, confused, or anxious
  • lose consciousness (faint)
  • have a fever, vomiting, sweating, shivering or shaking
  • have a fast heartbeat
• seizures (convulsions, fits)
• bleeding. Bleeding may happen if you have a condition that causes bleeding or if you take a blood thinning medicine.

Certain weight loss medicines have a rare but life-threatening problem that affects blood pressure in the lungs (pulmonary hypertension). It is not known if Meridia may cause this problem because pulmonary hypertension is so rare. Call your doctor right away if you have new or worsening shortness of breath.

The most common side effects of Meridia include:

• dry mouth
• loss of appetite
• trouble sleeping
• constipation
• headache

Tell your doctor if you get a rash or hives while taking Meridia. You may be having an allergic reaction.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the side effects of Meridia. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Meridia?

• Store Meridia between 59°F to 86° F (15°C to 30° C).
• Keep Meridia capsules dry and away from heat.
• Keep Meridia in a tightly closed container, and keep Meridia out of the light.
• Safely throw away medicine that is out of date or no longer needed.

Keep Meridia and all medicines out of reach of children.

General information about Meridia.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Meridia for a condition for which it was not prescribed. Do not give Meridia to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Meridia. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about Meridia that is written for health professionals.

For more information, go to www.Meridia.net, or call 1-800-633-9110.

What are the ingredients in Meridia?

Active ingredient: sibutramine hydrochloride monohydrate

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.

Hard-gelatin capsule: titanium dioxide, gelatin, FD&C Blue No. 2 (5 mg and 10 mg capsules only), D&C Yellow No. 10 (5 mg and 15 mg capsules only), and other inactive ingredients.

©Abbott

Manufactured for Abbott Laboratories, North Chicago, IL 60064 USA by KNOLL LLC B.V. Jayuya, PR, 00664.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rev. 08/2010

NDC 0074-2456-11

Meridia® CIV Sibutramine HCl Monohydrate 5 mg 30 Capsules Dispense the accompanying Medication Guide to each patient. Rx only Abbott

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, and fast heart rate.

Meridia may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not take any other prescription or over-the-counter weight-loss products without your doctor's advice.

Avoid taking cough and cold or allergy medications while taking Meridia.

Avoid drinking alcohol while taking Meridia.

There are no data on the excretion of sibutramine into human milk. Sibutramine is considered contraindicated during breast-feeding by the manufacturer. Patients should be advised to notify their physician if they are breast-feeding.

Summary of Use during Lactation

Because there is no published experience with sibutramine during breastfeeding, an alternate therapy may be preferred, especially while nursing a newborn or preterm infant. Information on the effect of sibutramine on serum prolactin is somewhat conflicting.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

In a study of hypocaloric diet plus sibutramine in overweight and obese patients with polycystic ovary syndrome, no change was seen in serum prolactin levels over the 6-month study period.[1]

A woman developed amenorrhea-galactorrhea syndrome shortly after starting therapy with sibutramine for weight loss. Her serum prolactin was elevated, but returned to normal within 15 days of discontinuing sibutramine. It remained in the normal range during the 180-day follow-up period.[2]

The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

References

1. Florakis D, Diamanti-Kandarakis E, Katsikis I et al. Effect of hypocaloric diet plus sibutramine treatment on hormonal and metabolic features in overweight and obese women with polycystic ovary syndrome: a randomized, 24-week study. Int J Obes (Lond). 2008;32:692-9. PMID: 18071341

2. Soares Leaes CG, Pereira-Lima JF, da Costa Oliveira M. A case of sibutramine-induced hyperprolactinemia. Neuro Endocrinol Lett. 2011;32:616-8. PMID: 22167128

LactMed Record Number

1000

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.