Last Updated on November 7, 2022 by
Weight loss is something that a lot of people have tried to do, and many have found success. But did you know that not all weight loss methods fit every person? If you’re struggling with weight loss or just feel the need to drop a few pounds to get back in shape, then keep reading because I’m going to tell you why Meridia may be a good fit for you.
We live in a society of materialism, where keeping up with your neighbors by acquiring the latest gadget or the best clothes is enough to determine your social status. Unfortunately weight is another form of status and many people are trying to keep up or be different by losing weight. But how do you lose weight without much effort? The answer is by using Meridia for Weight Loss. You can learn more about how Meridia For Weight Loss works by visiting my site at https://foodkeg.com/
Meridia For Weight Loss
Meridia is a prescription medicine used to treat the symptoms of obesity, weight loss and maintenance of weight loss. Meridia may be used alone or with other medications.
Meridia belongs to a class of drugs called Schedule IV controlled substances.
It is not known if Meridia is safe and effective in children younger than 16 years of age.
What are the possible side effects of Meridia?
Meridia may cause serious side effects including:
- fever,
- diarrhea,
- gas,
- stomach pain,
- tooth disorder,
- swelling in hands or feet,
- joint pain,
- agitation,
- leg cramps,
- hypertonia,
- unusual thoughts,
- upper respiratory infection,
- dyspnea,
- pruritus,
- amblyopia, and
- menstrual disorders
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Meridia include:
- dry mouth,
- loss of appetite,
- difficulty sleeping (insomnia),
- constipation, and
- headache
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible 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.
DESCRIPTION
MERIDIA® (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity. Chemically, the active ingredient is a racemic mixture of the (+) and (-) enantiomers of cyclobutanemethanamine, 1-(4-chlorophenyl)-N,N-dimethyl-α-(2-methylpropyl)-, hydrochloride, monohydrate, and has an empirical formula of C17H29Cl2NO. Its molecular weight is 334.33.
The structural formula is shown below:
 |
Sibutramine hydrochloride monohydrate is a white to cream crystalline powder with a solubility of 2.9 mg/mL in pH 5.2 water. Its octanol: water partition coefficient is 30.9 at pH 5.0.
Each MERIDIA capsule contains 5 mg, 10 mg, and 15 mg of sibutramine hydrochloride monohydrate. It also contains as inactive ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gelatin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only), and other inactive ingredients].
Before taking this medicine
Do not use Meridia 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 Meridia before the MAO inhibitor has cleared from your body. You should not take Meridia if you are allergic to Meridia, or if you have:
- severe or uncontrolled hypertension (high blood pressure);
- an eating disorder (anorexia or bulimia);
- a history of coronary artery disease (atherosclerosis);
- a history of heart disease (congestive heart failure, heart rhythm disorder);
- a history of heart attack or stroke; or
- if you are taking stimulant diet pills.
If you have any of these other conditions, you may need to adjust your dose of Meridia or have special tests:
- glaucoma;
- high blood pressure;
- liver disease;
- kidney disease;
- depression;
- underactive thyroid;
- epilepsy or seizure disorder;
- a bleeding or blood clotting disorder;
- a history of gallstones; or
- if you are older than 65 or younger than 16.
FDA pregnancy category C. It is not known whether Meridia will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Meridia. It is not known whether sibutramine passes into breast milk or if it could harm a nursing baby. Do not use Meridia without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 16 years old.
How should I take Meridia?
Take Meridia exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Meridia is usually taken once daily. Follow your doctor’s instructions.
Your doctor may occasionally change your dose to make sure you get the best results.
Meridia can be taken with or without food.
You should lose at least 4 pounds during the first 4 weeks of taking Meridia and eating a low calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks.
Your blood pressure and pulse will need to be checked often. Visit your doctor regularly.
Meridia should not be taken for longer than 2 years.
Store at room temperature away from moisture, heat, and light. Do not share Meridia with another person. Keep the medication in a place where others cannot get to it.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
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.
What should I avoid?
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.
INDICATIONS
MERIDIA (sibutramine 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. MERIDIA (sibutramine 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 ÷ 2.2 = kg; inches × 0.0254 = meters.
| BMI | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 40 | |
| W E I G H T (lbs) | |||||||||||||
| 4’10” | 119 | 124 | 129 | 134 | 138 | 143 | 149 | 153 | 158 | 163 | 167 | 191 | |
| 4’11” | 124 | 128 | 133 | 138 | 143 | 148 | 154 | 158 | 164 | 169 | 173 | 198 | |
| 5′ | 128 | 133 | 138 | 143 | 148 | 153 | 159 | 164 | 169 | 175 | 179 | 204 | |
| 5’1″ | 132 | 137 | 143 | 148 | 153 | 158 | 165 | 169 | 175 | 180 | 185 | 211 | |
| 5’2″ | 136 | 142 | 147 | 153 | 158 | 164 | 170 | 175 | 181 | 186 | 191 | 218 | |
| H | 5’3″ | 141 | 146 | 152 | 158 | 163 | 169 | 175 | 181 | 187 | 192 | 197 | 225 |
| 5’4″ | 145 | 151 | 157 | 163 | 169 | 174 | 181 | 187 | 193 | 199 | 204 | 232 | |
| E | 5’5″ | 150 | 156 | 162 | 168 | 174 | 180 | 187 | 193 | 199 | 205 | 210 | 240 |
| 5’6″ | 155 | 161 | 167 | 173 | 179 | 186 | 192 | 199 | 205 | 211 | 216 | 247 | |
| I | 5’7″ | 159 | 166 | 172 | 178 | 185 | 191 | 198 | 205 | 211 | 218 | 223 | 255 |
| 5’8″ | 164 | 171 | 177 | 184 | 190 | 197 | 204 | 211 | 218 | 224 | 230 | 262 | |
| G | 5’9″ | 169 | 176 | 182 | 189 | 196 | 203 | 210 | 217 | 224 | 231 | 236 | 270 |
| 5’10” | 174 | 181 | 188 | 195 | 202 | 207 | 216 | 223 | 230 | 237 | 243 | 278 | |
| H | 5’11” | 179 | 186 | 193 | 200 | 208 | 215 | 222 | 230 | 237 | 244 | 250 | 286 |
| 6′ | 184 | 191 | 199 | 206 | 213 | 221 | 228 | 236 | 244 | 251 | 258 | 294 | |
| T | 6’1″ | 189 | 197 | 204 | 212 | 219 | 227 | 236 | 243 | 251 | 258 | 265 | 302 |
| 6’2″ | 194 | 202 | 210 | 218 | 225 | 233 | 241 | 250 | 258 | 265 | 272 | 311 | |
| 6’3″ | 200 | 208 | 216 | 224 | 232 | 240 | 248 | 256 | 264 | 272 | 279 | 319 |
DOSAGE AND ADMINISTRATION
The recommended starting dose of MERIDIA (sibutramine 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, MERIDIA (sibutramine 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 MERIDIA (sibutramine 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 MERIDIA (sibutramine 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 MERIDIA (sibutramine 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 MERIDIA (sibutramine hydrochloride monohydrate) .
The safety and effectiveness of MERIDIA (sibutramine hydrochloride monohydrate) , as demonstrated in double-blind, placebo-controlled trials, have not been determined beyond 2 years at this time.
HOW SUPPLIED
MERIDIA® (sibutramine hydrochloride monohydrate) Capsules contain 5 mg, 10 mg, or 15 mg sibutramine hydrochloride monohydrate and are supplied as follows:
5 mg, NDC 0074-2456-12, blue/yellow capsules imprinted with “MERIDIA (sibutramine 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 ”MERIDIA (sibutramine 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 “MERIDIA (sibutramine 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) [see USP controlled room temperature]. 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.
Side Effects
SIDE EFFECTS
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.
Obese Patients in Placebo-Controlled Studies
| BODY SYSTEM Adverse Event | Sibutramine (n = 2068) % Incidence | Placebo (n = 884) % 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 incr ease | 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 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
Clinical Studies
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-cont rolled 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 trea ted 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.
Psychiatric
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.
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, otitisexterna, otitis media, photosensitivity (eyes), tinnitus.
Urogenital System: abnormal ejaculation, hematuria, impotence, increased urinary frequency, micturition difficulty, urinary retention.
Drug Abuse And Dependence
Controlled Substance
MERIDIA (sibutramine hydrochloride monohydrate) is controlled in Schedule IV of the Controlled Substances Act (CSA).
Abuse and Physical and Psychological Dependence
Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., drug development of tolerance, incrementation of doses, drug seeking behavior).
Drug Interactions
DRUG INTERACTIONS
CNS Active Drugs
The use of MERIDIA (sibutramine 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 MERIDIA (sibutramine hydrochloride monohydrate) with other centrally-acting drugs is indicated (see CONTRAINDICATIONS and WARNINGS).
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 sibutramine inhibits serotonin reuptake, MERIDIA should not be used concomitantly with a MAOI (see CONTRAINDICATIONS ). At least 2 weeks should elapse between discontinuation of a MAOI and initiation of treatment with MERIDIA (sibutramine hydrochloride monohydrate) . Similarly, at least 2 weeks should elapse between discontinuation of MERIDIA (sibutramine 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 sibutramine 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 MERIDIA (sibutramine 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 MERIDIA (sibutramine 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 sibutramine resulted in no psychomotor interactions of clinical significance between alcohol and sibutramine. However, the concomitant use of MERIDIA (sibutramine hydrochloride monohydrate) and excess alcohol is not recommended.
Oral Contraceptives
The suppression of ovulation by oral contraceptives was not inhibited by sibutramine. In a crossover study, 12 healthy female volunteers on oral steroid contraceptives received placebo in one period and 15 mg sibutramine 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 sibutramine.
Warnings
WARNINGS
Concomitant Cardiovascular Disease
Due to an increased risk of heart attack and stroke in patients with cardiovascular disease, MERIDIA (sibutramine hydrochloride monohydrate) should not be used in patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Blood Pressure and Pulse
MERIDIA (sibutramine hydrochloride monohydrate) SUBSTANTIALLY INCREASES BLOOD PRESSURE AND/OR PULSE RATE IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE AND PULSE RATE IS REQ UIRED WHEN PRESCRIBING MERIDIA (sibutramine hydrochloride monohydrate) .
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 f or 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 ≥ 100bpm), compared with 0.1% in the placebo group. Blood pressure and pulse should be measured prior to starting therapy with MERIDIA (sibutramine hydrochloride monohydrate) and should be monitored at regular intervals thereafter. For patients who experience a sustained increase in blood pressure or pulse rate while receiving MERIDIA (sibutramine hydrochloride monohydrate) , either dose reduction or discontinuation should be considered. MERIDIA (sibutramine hydrochloride monohydrate) 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.
Percent Outliers in Studies 1 and 2
| Dose (mg) | SBP | % Outliers* | |
| DBP | Pulse | ||
| Placebo | 9 | 7 | 12 |
| 5 | 6 | 20 | 16 |
| 10 | 12 | 15 | 28 |
| 15 | 13 | 17 | 24 |
| 20 | 14 | 22 | 37 |
| * Outlier defined as increase from baseline of ≥ 15 mm Hg for three consecutive visits (SBP), ≥ 10 mm Hg for three consecutive visits (DBP), or pulse ≥ 10 bpm for three consecutive visits. |
Potential Interaction With Monoamine Oxidase Inhibitors
MERIDIA (sibutramine hydrochloride monohydrate) 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 (sibutramine hydrochloride monohydrate) . Similarly, there should be at least a 2-week interval after stopping MERIDIA (sibutramine hydrochloride monohydrate) 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 (sibutramine hydrochloride monohydrate) 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]. 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 (sibutramine hydrochloride monohydrate) 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 (sibutramine hydrochloride monohydrate) .