### CLENMED 40 (clenbuterol hydrochloride) Tablets
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use CLENMED 40 safely and effectively. See full prescribing information for CLENMED 40.
CLENMED 40 (clenbuterol hydrochloride) tablets, for oral use
**INDICATIONS AND USAGE**
CLENMED 40 is a beta-2 agonist indicated for investigational use in promoting fat loss, preserving muscle mass, and enhancing cardiovascular performance in performance enhancement settings. Not approved for human use in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Administer orally; taper dose to minimize side effects.
– Adult males: 40 mcg to 120 mcg per day.
– Adult females: 20 mcg to 80 mcg per day (2.1).
– Cycle duration: Typically 2 weeks on, 2 weeks off, up to 12 weeks.
**DOSAGE FORMS AND STRENGTHS**
Tablets: 40 mcg clenbuterol hydrochloride (3).
**CONTRAINDICATIONS**
– Hypersensitivity to clenbuterol or any component of the formulation (4).
– Cardiovascular disease (e.g., hypertension, arrhythmias) (4).
– Hyperthyroidism or glaucoma (4).
– Pregnancy (4).
**WARNINGS AND PRECAUTIONS**
– Cardiovascular effects: May cause tachycardia or hypertension; monitor heart rate (5.1).
– Electrolyte imbalance: Risk of hypokalemia; monitor potassium levels (5.2).
– Tolerance: Prolonged use may reduce efficacy; follow cycling protocol (5.3).
– Neurological effects: May cause tremors or insomnia; avoid stimulants (5.4).
**ADVERSE REACTIONS**
Common adverse reactions include tremors, palpitations, headache, insomnia, and muscle cramps (6).
**DRUG INTERACTIONS**
– Beta-blockers: May antagonize effects (7.1).
– Stimulants: Increased cardiovascular risk (7.2).
**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Contraindicated (8.1).
– Lactation: Not recommended (8.2).
– Pediatric use: Safety not established (8.4).
– Geriatric use: Increased cardiovascular risk (8.5).
Revised: 08/2025
**FULL PRESCRIBING INFORMATION**
**1 INDICATIONS AND USAGE**
CLENMED 40 is indicated for investigational use in adults to accelerate fat loss, improve metabolic rate, preserve lean muscle during calorie deficits, enhance cardiovascular performance, increase oxygen uptake, and reduce appetite. It is commonly used in cutting cycles for bodybuilding to achieve a leaner physique. This product is not approved for clinical use and should be administered under medical supervision.
**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Administer orally, preferably in the morning to minimize insomnia. Start at a low dose (e.g., 20 mcg) and taper up to assess tolerance.
– Males: 40 mcg to 120 mcg daily, adjusted based on tolerance.
– Females: 20 mcg to 80 mcg daily, adjusted based on tolerance.
– Cycle: 2 weeks on, 2 weeks off, up to 12 weeks. Discontinue if adverse effects occur.
**2.2 Preparation and Handling**
Store tablets in original packaging to protect from moisture. Do not crush or chew tablets.
**3 DOSAGE FORMS AND STRENGTHS**
Tablets containing 40 mcg clenbuterol hydrochloride, supplied in bottles of 100 tablets.
**4 CONTRAINDICATIONS**
CLENMED 40 is contraindicated in:
– Patients with hypersensitivity to clenbuterol or excipients (e.g., lactose monohydrate).
– Patients with cardiovascular disease, including hypertension or arrhythmias.
– Patients with hyperthyroidism or glaucoma.
– Pregnant women (Category X).
**5 WARNINGS AND PRECAUTIONS**
**5.1 Cardiovascular Effects**
Clenbuterol may cause tachycardia, palpitations, or hypertension due to beta-2 receptor stimulation. Monitor heart rate and blood pressure regularly, especially in patients with cardiovascular risk factors.
**5.2 Electrolyte Imbalance**
Risk of hypokalemia or hypomagnesemia, which may lead to muscle cramps or arrhythmias. Monitor electrolyte levels and ensure adequate hydration during use.
**5.3 Tolerance and Dependence**
Prolonged use may lead to receptor downregulation, reducing efficacy. Adhere to recommended 2-week on/off cycling protocol to minimize tolerance.
**5.4 Neurological Effects**
May cause tremors, insomnia, or anxiety, particularly at higher doses. Avoid concurrent use of other stimulants (e.g., caffeine) to reduce risk of exacerbation.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Nervous System: Tremors, headache, insomnia, anxiety, nervousness.
– Cardiovascular: Palpitations, tachycardia, hypertension.
– Musculoskeletal: Muscle cramps, muscle spasms.
– Metabolic: Increased sweating, hypokalemia.
Serious reactions may include cardiac arrhythmias or severe electrolyte imbalances.
**7 DRUG INTERACTIONS**
**7.1 Beta-Blockers**
Beta-blockers (e.g., propranolol) may antagonize clenbuterol’s effects, reducing efficacy. Avoid concurrent use unless medically supervised.
**7.2 Stimulants**
Concurrent use with caffeine or other stimulants may increase cardiovascular side effects, such as tachycardia or hypertension. Use with caution.
**7.3 Theophylline**
May enhance toxicity when used with theophylline; monitor for increased side effects.
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
Category X: May cause fetal harm due to cardiovascular stimulation. Contraindicated in pregnant women.
**8.2 Lactation**
Excretion in breast milk is unknown; breastfeeding is not recommended due to potential risks to the infant.
**8.4 Pediatric Use**
Safety and efficacy not established in pediatric patients; use is not recommended.
**8.5 Geriatric Use**
Increased risk of cardiovascular side effects; use with caution and monitor heart function closely.
**9 DRUG ABUSE AND DEPENDENCE**
Potential for misuse in performance enhancement settings. No evidence of physical dependence, but psychological dependence may occur with chronic use.
**10 OVERDOSAGE**
Symptoms of overdose may include severe tachycardia, hypokalemia, tremors, or seizures. No specific antidote exists; treat symptomatically, and beta-blockers may be considered under medical supervision.
**11 DESCRIPTION**
CLENMED 40 contains clenbuterol hydrochloride, a beta-2 adrenergic agonist with bronchodilator and thermogenic properties. Supplied as 40 mcg tablets for oral use. Excipients include lactose monohydrate, microcrystalline cellulose, and magnesium stearate. Half-life: Approximately 36 hours.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Clenbuterol stimulates beta-2 adrenergic receptors, increasing metabolic rate, thermogenesis, and oxygen uptake while preserving muscle mass during caloric deficits.
**12.3 Pharmacokinetics**
Rapidly absorbed after oral administration; peak plasma levels in 2-3 hours; half-life approximately 36 hours; metabolized in the liver; excreted primarily in urine.
**13 NONCLINICAL TOXICOLOGY**
Animal studies indicate potential for cardiac hypertrophy at high doses; no human carcinogenicity data available. Use caution due to cardiovascular risks.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
Tablets, 40 mcg, in bottles of 100. Store at 20°-25°C (68°-77°F); protect from moisture. Keep out of reach of children.
*Manufactured by: Medi Pharma*
