What is Biomag?
Biomag was withdrawn from the U.S. market in October 2010.
Biomag affects chemicals in the brain that affect weight maintenance.
Biomag is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure.
Biomag may also be used for other purposes not listed in this medication guide.
Biomag indications
Biomag (Biomag hydrochloride monohydrate) is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. Biomag (Biomag hydrochloride monohydrate) is recommended for obese patients with an initial body mass index ≥ 30 kg/m², or ≥ 27 kg/m² in the presence of other risk factors (e.g., diabetes, dyslipidemia, controlled hypertension).
Below is a chart of Body Mass Index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kg, and dividing by the patient's height, in meters, squared. Metric conversions are as follows: pounds
How should I use Biomag?
Use Biomag as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Biomag. Talk to your pharmacist if you have questions about this information.
- Take Biomag by mouth with or without food.
- Unless otherwise directed by your doctor, Biomag should be taken in the morning to avoid sleeping problems.
- If you miss a dose of Biomag, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Biomag.
Uses of Biomag in details
Biomag is used in the treatment of obesity along with the dietary recommendation. However, this drug has been withdrawn from the market as it has an increased risk of heart attack and stroke.
Biomag description
Biomag (trade name Biomag in the USA, Reductil in Europe and other countries), usually as sibutramide hydrochloride monohydrate, is an orally administered agent for the treatment of obesity. It is a centrally acting stimulant chemically related to amphetamines. Biomag is classified as a Schedule IV controlled substance in the United States. In October 2010, Biomag was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.
Biomag dosage
The recommended starting dose of Biomag (Biomag hydrochloride monohydrate) is 10 mg administered once daily with or without food. If there is inadequate weight loss, the dose may be titrated after four weeks to a total of 15 mg once daily. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration.
Doses above 15 mg daily are not recommended. In most of the clinical trials, Biomag (Biomag hydrochloride monohydrate) was given in the morning.
Analysis of numerous variable s has indicated that approximately 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with a given dose of Biomag (Biomag hydrochloride monohydrate) in combination with a reduced-calorie diet lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose of Biomag (Biomag hydrochloride monohydrate). Conversely, approximately 80% of patients who do not lose at least 4 pounds in the first 4 weeks of treatment with a given dose of Biomag (Biomag hydrochloride monohydrate) do not lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose. If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the physician should consider reevaluation of therapy which may include increasing the dose or discontinuation of Biomag (Biomag hydrochloride monohydrate).
The safety and effectiveness of Biomag (Biomag hydrochloride monohydrate), as demonstrated in double-blind, placebo-controlled trials, have not been determined beyond 2 years at this time.
How supplied
Biomag® (Biomag hydrochloride monohydrate) Capsules contain 5 mg, 10 mg, or 15 mg Biomag hydrochloride monohydrate and are supplied as follows:
5 mg, NDC 0074-2456-12, blue/yellow capsules imprinted with “Biomag (Biomag hydrochloride monohydrate) ” on the cap and ”-5-“ on the body, in bottles of 30 capsules.
10 mg, NDC 0074-2457-12, blue/white capsules imprinted with ”Biomag (Biomag hydrochloride monohydrate) ” on the cap and “-10-” on the body, in bottles of 30 capsules.
15 mg, NDC 0074-2458-12, yellow/white capsules imprinted with “Biomag (Biomag hydrochloride monohydrate) ” on the cap and “-15-” on the body, in bottles of 30 capsules.
Storage
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect capsules from heat and moisture. Dispense in a tight, light-resistant container as defined in USP.
Manufactured for Abbott Laboratories, North Chicago, IL 60064 USA by KNOLL LLC B.V. Jayuya, PR, 00664.
Biomag interactions
See also:
What other drugs will affect Biomag?
CNS Active Drugs
The use of Biomag (Biomag hydrochloride monohydrate) in combination with other CNS-active drugs, particularly serotonergic agents, has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of Biomag (Biomag hydrochloride monohydrate) with other centrally-acting drugs is indicated.
In patients receiving monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, selegiline) in combination with serotonergic agents (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine), there have been reports of serious, sometimes fatal, reactions (“serotonin syndrome;” see below). Because Biomag inhibits serotonin reuptake, Biomag should not be used concomitantly with a MAOI. At least 2 weeks should elapse between discontinuation of a MAOI and initiation of treatment with Biomag (Biomag hydrochloride monohydrate). Similarly, at least 2 weeks should elapse between discontinuation of Biomag (Biomag hydrochloride monohydrate) and initiation of treatment with a MAOI.
The rare, but serious, constellation of symptoms term ed “serotonin syndrome” has also been reported with the concomitant use of selective serotonin reuptake inhibitors and agents for migraine therapy, such as Imitrex® (sumatriptan succinate) and dihydroergotamine, certain opioids, such as dextromethorphan, meperidine, pentazocine and fentanyl, lithium, or tryptophan. Serotonin syndrome has also been reported with the concomitant use of two serotonin reuptake inhibitors. The syndrome requires immediate medical attention and may inclu de one or more of the following symptoms: excitement, hypomania, restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, motor weakness, myoclonus, tremor, hemiballismus, hyperreflexia, ataxia, dysarthria, incoordination, hyperthermia, shivering, pupillary dilation, diaphoresis, emesis, and tachycardia.
Because Biomag inhibits serotonin reuptake, in general, it should not be administered with other serotonergic agents such as those listed above. However, if such a combination is clinically indicated, appropriate observation of the patient is warranted.
Drugs That May Raise Blood Pressure and/or Heart Rate
Concomitant use of Biomag (Biomag hydrochloride monohydrate) and other agents that may raise blood pressure or heart rate have not been evaluated. These include certain decongestants, cough, cold, and allergy medications that contain agents such as ephedrine, or pseudoephedrine. Caution should be used when prescribing Biomag (Biomag hydrochloride monohydrate) to patients who use these medications.
Alcohol
In a double-blind, placebo-controlled, crossover study in 19 volunteers, administration of a single dose of ethanol (0.5 mL/kg) together with 20 mg of Biomag resulted in no psychomotor interactions of clinical significance between alcohol and Biomag. However, the concomitant use of Biomag (Biomag hydrochloride monohydrate) and excess alcohol is not recommended.
Oral Contraceptives
The suppression of ovulation by oral contraceptives was not inhibited by Biomag. In a crossover study, 12 healthy female volunteers on oral steroid contraceptives received placebo in one period and 15 mg Biomag in another period over the course of 8 weeks. No clinically significant systemic interaction was observed; therefore, no requirement for alternative contraceptive precautions are needed when patients taking oral contraceptives are concurrently prescribed Biomag.
Biomag side effects
See also:
What are the possible side effects of Biomag?
In placebo-controlled studies, 9% of patients treated with Biomag (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 Biomag treated patients and more frequently than in the placebo group are shown in the following table.
| BODY SYSTEM Adverse Event | Biomag (n = 2068) | Placebo (n = 884) |
| % Incidence | % Incidence | |
| BODY AS A WHOLE: | ||
| Headache | 30.3 | 18.6 |
| Back pain | 8.2 | 5.5 |
| Flu syndrome | 8.2 | 5.8 |
| Injury accident | 5.9 | 4.1 |
| Asthenia | 5.9 | 5.3 |
| Abdominal pain | 4.5 | 3.6 |
| Chest pain | 1.8 | 1.2 |
| Neck pain | 1.6 | 1.1 |
| Allergic reaction | 1.5 | 0.8 |
| CARDIOVASCULAR SYSTEM | ||
| Tachycardia | 2.6 | 0.6 |
| Vasodilation | 2.4 | 0.9 |
| Migraine | 2.4 | 2.0 |
| Hypertension/increased blood pressure | 2.1 | 0.9 |
| Palpitation | 2.0 | 0.8 |
| DIGESTIVE SYSTEM | ||
| Anorexia | 13.0 | 3.5 |
| Constipation | 11.5 | 6.0 |
| Increased appetite | 8.7 | 2.7 |
| Nausea | 5.9 | 2.8 |
| Dyspepsia | 5.0 | 2.6 |
| Gastritis | 1.7 | 1.2 |
| Vomiting | 1.5 | 1.4 |
| Rectal disorder | 1.2 | 0.5 |
| METABOLIC & NUTRITIONAL | ||
| Thirst | 1.7 | 0.9 |
| Generalized edema | 1.2 | 0.8 |
| MUSCULOSKELETAL SYSTEM | ||
| Arthralgia | 5.9 | 5.0 |
| Myalgia | 1.9 | 1.1 |
| Tenosynovitis | 1.2 | 0.5 |
| Joint disorder | 1.1 | 0.6 |
| NERVOUS SYSTEM | ||
| Dry mouth | 17.2 | 4.2 |
| Insomnia | 10.7 | 4.5 |
| Dizziness | 7.0 | 3.4 |
| Nervousness | 5.2 | 2.9 |
| Anxiety | 4.5 | 3.4 |
| Depression | 4.3 | 2.5 |
| Paresthesia | 2.0 | 0.5 |
| Somnolence | 1.7 | 0.9 |
| CNS stimulation | 1.5 | 0.5 |
| Emotional lability | 1.3 | 0.6 |
| RESPIRATORY SYSTEM | ||
| Rhinitis | 10.2 | 7.1 |
| Pharyngitis | 10.0 | 8.4 |
| Sinusitis | 5.0 | 2.6 |
| Cough increase | 3.8 | 3.3 |
| Laryngitis | 1.3 | 0.9 |
| SKIN & APPENDAGES | ||
| Rash | 3.8 | 2.5 |
| Sweating | 2.5 | 0.9 |
| Herpes simplex | 1.3 | 1.0 |
| Acne | 1.0 | 0.8 |
| SPECIAL SENSES | ||
| Taste perversion | 2.2 | 0.8 |
| Ear disorder | 1.7 | 0.9 |
| Ear pain | 1.1 | 0.7 |
| UROGENITAL SYSTEM | ||
| Dysmenorrhea | 3.5 | 1.4 |
| Urinary tract infection | 2.3 | 2.0 |
| Vaginal monilia | 1.2 | 0.5 |
| Metrorrhagia | 1.0 | 0.8 |
The following additional adverse events were reported in ≥ 1% of all patients who received Biomag 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
Clinical Studies
Seizures
Convulsions were reported as an adverse event in three of 2068 (0.1%) Biomag 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 Biomag (three of 4,588 subjects) was less than 0.1%.
Ecchymosis/Bleeding Disorders
Ecchymosis (bruising) was observed in 0.7% of Biomag 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. Biomag 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 Biomag 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 Biomag-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 Biomag 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 Biomag are listed below. It is important to emphasize that although these events occurred during treatment with Biomag, 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.
Psychiatric
Cases of depression, psychosis, mania, suicidal ideation and suicide have been reported rarely in patients on Biomag treatment. However, a relationship has not been established between these events and the use of Biomag. If any of these events should occur during treatment with Biomag, discontinuation should be considered.
Hypersensitivity
Allergic hypersensitivity reactions ranging from mild skin eruptions and urticaria to angioedema and anaphylaxis have been reported.
Other Postmarketing Reported Events:
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.
Biomag contraindications
See also:
What is the most important information I should know about Biomag?
Biomag was withdrawn from the U.S. market in October 2010.
Do not use Biomag if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use Biomag before the MAO inhibitor has cleared from your body.
You should not take Biomag if you are allergic to it, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), if you are taking stimulant diet pills, or if you have a history of coronary artery disease, stroke, or heart disease.
Before taking Biomag, tell your doctor if you have glaucoma, high blood pressure, liver or kidney disease, depression, underactive thyroid, seizures, a bleeding disorder, a history of gallstones, or if you are older than 65 or younger than 16.
Tell your doctor about all prescription and over-the-counter medications you use, especially antidepressants, cold or allergy medication, narcotic pain medicine, or migraine headache medicines.
Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.
Active ingredient matches for Biomag:
Sibutramine in Argentina, Brazil, Italy.
Ambra grisea/kalium phosphoricum/magnesii chloras/magnesii phosphas/magnesii stearate in Canada, France.
Cimetidine in Italy.
Magnesium Pidolate in Argentina, Brazil, Italy.
Magnesium lactate in Poland.
Magnesium sulphate in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| Tablet; Oral; Ambra Grisea; Magnesium Chlorate 5 x; Magnesium 1 x; Phosphate Dibasic 1 x; Magnesium Stearate 3 x; Plumbum Metallicum 8 x; Potassium Phosphate Dibasic 5 x | |
| 25 % w/v x 2ml | $ 0.10 |
| 50 % w/v x 2ml | $ 0.13 |
| BIOMAG inj 25 % w/v x 2ml (Zygood) | $ 0.17 |
| BIOMAG inj 50 % w/v x 2ml (Zygood) | $ 0.27 |
List of Biomag substitutes (brand and generic names): | |
| Bio-Cimetidine (South Africa) | |
| Biomag 800 (Italy) | |
| Blocan (Mexico) | |
| Brumetidina (Ethiopia, Italy, Vietnam) | |
| Brumetidina 200 mg x 10 Blister x 10 Tablet (Bruschettini) | |
| Brumetidina 400 mg x 10 Blister x 10 Tablet (Bruschettini) | |
| Brumetidina 400 (Vietnam) | |
| Butaslim (Pakistan) | |
| Butram 10 | |
| Butram 15 | |
| Butram 5 | |
| Butramin (Bangladesh, Colombia) | |
| C Met | |
| C Met 400 mg Tablet (Cyper Pharma) | $ 0.02 |
| C.M.T. (Taiwan) | |
| C.M.T. 200 mg x 100's | |
| C.M.T. 200 mg x 500's | |
| C.M.T. 400 mg x 500's | |
| Cavimet (Venezuela) | |
| Cdin (Ethiopia) | |
| Cedine (Ireland) | |
| Cedine 200 | |
| Cedine 400 | |
| Celtec (Colombia) | |
| Cementin (Hong Kong, Singapore) | |
| Cementin 200 mg x 10 x 10 x 10's (Dha) | |
| Cementin 200 mg x 1000's (Dha) | |
| Cementin 200 mg x 1000 Tablet (Dha) | |
| Cemidin (Israel) | |
| Caplets; Oral; Cimetidine 400 mg (Dexxon) | |
| Caplets; Oral; Cimetidine 800 mg (Dexxon) | |
| Tablet; Oral; Cimetidine 200 mg (Dexxon) | |
| Cencamat (Thailand) | |
| Cencamat 200 mg x 100 x 10's | |
| Cencamat 400 mg x 100 x 10's | |
| Cencamat 400 mg x 1, 000's | |
| Cencamet (Thailand) | |
| Cetonid (Ecuador) | |
| Cetonil (Argentina, Costa Rica, Dominican Republic, El Salvador, Nicaragua) | |
| Changfu YouShu (China) | |
| Chintamet (Thailand) | |
| Chintamet 400 mg x 500's | |
| Ciclem (Philippines) | |
| Ciclem 200 mg x 100's (Pharmacare) | $ 12.83 |
| Cidine (Spain, Thailand) | |
| Cidine 400 mg x 500's (Medifive) | |
| Cigamate (Taiwan) | |
| Cigamate 20 mg/1 mL x 10 mL | |
| Cigamet (Thailand) | |
| Cigamet 200 mg x 100's (General Drugs House) | |
| Cigamet / foil 200 mg x 20 x 10's (General Drugs House) | |
| Cigamet 200 mg x 1, 000's (General Drugs House) | |
| Cigamet / foil 400 mg x 10 x 10's (General Drugs House) | |
See 1660 substitutes for Biomag | |
References
- DailyMed. "SIBUTRAMINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "MAGNESIUM CHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "CIMETIDINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Biomag are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Biomag. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yet1 consumer reported age
| Users | % | ||
|---|---|---|---|
| 16-29 | 1 | 100.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
