Tetralin

Description

Tetralin Capsule

Generic Name: Tetracycline Hydrochloride

Manufacturer: S.R. Drug Laboratories Pvt. Ltd.

Availability: Nepal

Indications

Tetralin Capsule is prescribed for the treatment of various bacterial infections, including:

• Acne
• Lyme disease
• Uncomplicated gonorrhea
• Syphilis
• Psittacosis
• Q fever
• Pleural effusions (fluid accumulation around the lungs)
• Rocky Mountain spotted fever
• Lymphogranuloma venereum
• Mycoplasma pneumoniae infections
• Trachoma
• Nongonococcal urethritis
• Vibrio cholera
• Brucellosis

Dosage and Administration

Route: Oral

Important: For best absorption, take on an empty stomach, either 1 hour before or 2 hours after meals, with a full glass of water, and remain in an upright position. If gastrointestinal discomfort occurs, it may be taken with meals.

Adult Dose:

• Susceptible Infections: 250-500 mg every 6 hours. Maximum: 4 grams per day.
• Acne: 250-500 mg daily, in divided doses, for at least 3 months.
• Syphilis: 500 mg 4 times daily for 15 days.
• Gonorrhea: 500 mg 4 times daily for 7 days.
• Vibrio Cholera: 500 mg 4 times daily for 3 days.
• Brucellosis: 500 mg 4 times daily for 3 weeks, in combination with streptomycin.
• Hepatic Impairment: Maximum: 1 gram daily.

Child Dose:

• Children <8 years: Not recommended due to risk of permanent tooth discoloration.
• Children >8 years: 25–50 mg/kg/day, administered every 6 hours. Do not exceed 3 grams per day.

Renal Impairment Dosage Adjustments:

• Creatinine Clearance (CrCl) 50-80 mL/min: Dose frequency every 8-12 hours.
• CrCl 10-50 mL/min: Dose frequency every 12-24 hours.
• CrCl <10 mL/min: Dose frequency every 24 hours.

Contraindications

Tetralin Capsule should not be used in individuals with:

• Hypersensitivity to tetracycline or any of its components.
• Pregnancy or lactation.
• Children under 8 years of age.
• Renal impairment.

Precautions

• Use with caution in patients with pre-existing Systemic Lupus Erythematosus (SLE) or myasthenia gravis.
• Caution is advised for patients with hepatic and mild to moderate renal impairment.
• Patient Counseling: Avoid direct exposure to sunlight or UV light (e.g., sunbeds) during treatment, as this medication can increase photosensitivity.
• Monitoring Parameters: Regular monitoring of renal, hepatic, and hematologic function tests, temperature, white blood cell (WBC) count, cultures and sensitivity, appetite, and mental status is recommended.

Pregnancy and Lactation

Tetracycline is contraindicated during pregnancy and lactation due to the risk of permanent tooth discoloration and enamel hypoplasia in the developing fetus or infant.

Interactions

• Impaired Absorption: Absorption may be significantly reduced by concurrent use with antacids containing divalent and trivalent cations (e.g., aluminum, calcium, magnesium), iron, zinc, sodium bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol, and colestyramine. Administer Tetralin at least 1-2 hours before or after these agents.
• Antibiotics: May interfere with the bactericidal action of penicillin.
• Anticoagulants: May potentiate the effect of oral anticoagulants (e.g., warfarin), increasing the risk of bleeding. Close monitoring of INR is advised.
• Oral Contraceptives: May decrease the efficacy of oral contraceptives, leading to an increased risk of unintended pregnancy.
• Nephrotoxic Drugs: Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs.
• Antidiabetic Drugs: May increase the hypoglycemic effect of insulin and sulfonylureas in patients with diabetes mellitus.
• Other Drugs: May increase the toxic effects of ergot alkaloids and methotrexate.
• Potentially Fatal Interactions:
  • Concurrent use with methoxyflurane may result in fatal renal toxicity.
  • Increased risk of benign intracranial hypertension when used with Vitamin A or retinoids (e.g., acitretin, isotretinoin, tretinoin).

Adverse Effects

Very Common (>10%):

• Discoloration of teeth and enamel hypoplasia (especially in young children).

Common (1-10%):

• Diarrhea
• Nausea
• Photosensitivity (increased sensitivity to sunlight)

Less Common (<1%):

• Anorexia
• Abdominal cramps
• Antibiotic-associated pseudomembranous colitis
• Bulging fontanels in infants
• Diabetes insipidus syndrome
• Esophagitis
• Exfoliative dermatitis (severe skin peeling)
• Increased intracranial pressure (ICP)
• Pericarditis (inflammation around the heart)
• Pseudotumor cerebri (a condition mimicking a brain tumor)
• Pancreatitis (inflammation of the pancreas)
• Pruritus (itching)
• Pigmentation of nails
• Vomiting

Potentially Fatal Adverse Effects:

• Anaphylaxis (severe allergic reaction)
• Hepatotoxicity (liver damage)
• Nephrotoxicity (kidney damage)
• Blood dyscrasias (blood disorders)

Mechanism of Action

Tetracycline exerts its bacteriostatic action by reversibly binding to the 30S ribosomal subunit of susceptible bacteria. This binding prevents protein synthesis, thereby arresting cell growth. It demonstrates a broad spectrum of antimicrobial activity against various Chlamydiaceae, Mycoplasma species, Rickettsia species, spirochetes, many aerobic and anaerobic gram-positive and gram-negative pathogenic bacteria, and some protozoa.

Important Note: The information provided here for Tetralin Capsule is intended for general informational purposes only and does not constitute medical advice. It is not a substitute for professional medical judgment, diagnosis, or treatment. Always consult with a qualified healthcare professional for any medical concerns or before making any decisions related to your health or treatment.