Renamycin250 mg

Rickettsial Infections

Renamycin is an established treatment for infections caused by Rickettsia species, including Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers, when tetracycline-class therapy is appropriate for the patient.

Mycoplasma, Chlamydial and Related Infections

Renamycin is indicated for respiratory tract infections caused by Mycoplasma pneumoniae, for psittacosis/ornithosis caused by Chlamydophila psittaci, and for infections caused by Chlamydia trachomatis such as lymphogranuloma venereum, trachoma, and inclusion conjunctivitis (uncomplicated urethral, endocervical, or rectal chlamydial infection in adults is preferably treated with other guideline-preferred agents; Renamycin is an alternative option per susceptibility).

Susceptible Bacterial Infections

Renamycin is indicated for a range of infections caused by susceptible Gram-positive and Gram-negative organisms, including certain respiratory tract infections, skin and soft-tissue infections, and urinary tract infections, when susceptibility testing supports its use and when more narrow-spectrum agents are unsuitable.

Sexually Transmitted Infections (Alternative Therapy)

Renamycin is established as an alternative treatment for uncomplicated gonorrhea and for syphilis in patients who are hypersensitive to penicillin, and for chancroid caused by Haemophilus ducreyi, per susceptibility and when first-line agents cannot be used.

Other Established and Adjunct Uses

Renamycin is used, usually in combination with streptomycin, for brucellosis (combination therapy, not Renamycin alone, is required for adequate cure); together with an aminoglycoside for tularemia and plague as an alternative agent; as an adjunct to amebicides in intestinal amebiasis; and as an adjunctive, limited-course treatment for inflammatory acne vulgaris in adults, consistent with antibiotic stewardship principles.

Topical/Ophthalmic Use

Topical and ophthalmic formulations containing Renamycin (often combined with polymyxin B) are used, per local product labeling, for susceptible superficial bacterial infections of the eye (such as bacterial conjunctivitis) and skin; these formulations are dosed and used differently from systemic Renamycin and are not a substitute for treatment of deep or systemic infection.

Not Indicated For

Renamycin is not effective against viral infections such as the common cold or influenza, and inappropriate use of Renamycin for such conditions contributes to antibiotic resistance.

Each capsule or tablet contains Oxytetracycline (as Oxytetracycline hydrochloride) 250 mg or 500 mg, depending on the marketed strength; injectable and ophthalmic/topical formulations of Oxytetracycline are also available in some markets.

Renamycin is a broad-spectrum antibiotic belonging to the tetracycline class of medicines, one of the older agents in this class, used to treat a variety of bacterial, rickettsial, and chlamydial infections. Renamycin works by stopping susceptible bacteria from producing the proteins they need to grow and multiply. Renamycin is commonly used for rickettsial diseases, certain respiratory and skin infections, as alternative therapy for some sexually transmitted infections, and, in topical/ophthalmic form, for superficial eye and skin infections. Renamycin does not treat viral infections such as the common cold or flu, and Renamycin should be taken exactly as prescribed by a qualified healthcare professional.

Antibiotic (Tetracycline-class)

Oxytetracycline is absorbed from the gastrointestinal tract after oral administration, although absorption of Oxytetracycline is incomplete and is significantly reduced by food, dairy products, and polyvalent cations (calcium, magnesium, iron, aluminum, zinc, bismuth), which chelate Oxytetracycline in the gut. Oxytetracycline is widely distributed in body tissues and fluids, crosses the placenta, and is deposited in growing bone and developing teeth, where it binds to calcium. Oxytetracycline undergoes little to no hepatic metabolism and is excreted mainly unchanged, both in urine (via glomerular filtration) and in bile/feces; unlike some newer tetracyclines, elimination of Oxytetracycline is significantly affected by renal function, so Oxytetracycline tends to accumulate in patients with renal impairment. The elimination half-life of Oxytetracycline is approximately 6 to 10 hours in patients with normal renal function.

• Take Renamycin on an empty stomach, at least 1 hour before or 2 hours after meals, with a full glass of water, since food and dairy products significantly reduce absorption of Renamycin.
• Do not take Renamycin at the same time as milk, other dairy products, antacids, or calcium, iron, magnesium, or zinc supplements; separate these by at least 2–3 hours from a dose of Renamycin.
• Remain sitting or standing (do not lie down) for at least 30–60 minutes after taking Renamycin to reduce the risk of esophageal irritation or ulceration.
• Use effective sun protection (sunscreen, protective clothing) and limit prolonged sun/UV exposure, as Renamycin can increase sensitivity to sunlight.
• Take Renamycin exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

• Antacids, dairy products, and calcium, iron, magnesium, or zinc supplements: these form insoluble complexes (chelates) with Renamycin in the gut, substantially reducing absorption of Renamycin; separate dosing by several hours.
• Hormonal (oral) contraceptives: Renamycin may reduce contraceptive efficacy; advise an additional or backup contraceptive method while taking Renamycin.
• Warfarin and other anticoagulants: Renamycin may potentiate anticoagulant effect by depressing plasma prothrombin activity, requiring closer INR monitoring and possible dose adjustment.
• Penicillin-class antibiotics: the bacteriostatic action of Renamycin may antagonize the bactericidal action of penicillins; concurrent use is generally avoided.
• Digoxin: in a small subset of patients, Renamycin can increase absorption/levels of digoxin by altering gut flora that normally inactivate it, increasing the risk of digoxin toxicity; monitor if used together.
• Methoxyflurane and other potentially nephrotoxic drugs: concurrent use with Renamycin has been associated with fatal nephrotoxicity; avoid combination.
• Retinoids (e.g., isotretinoin): concurrent use with Renamycin increases the risk of intracranial hypertension (pseudotumor cerebri); concurrent use should be avoided.

Common Side Effects

• Nausea, vomiting, diarrhea, and abdominal discomfort
• Loss of appetite
• Photosensitivity (increased sunburn-type skin reaction)
• Mild skin rash

Serious Side Effects (Seek Medical Attention)

• Permanent tooth discoloration or enamel hypoplasia if Renamycin is used in children under 8 years or during pregnancy — see Contraindications
• Severe chest pain or pain/difficulty swallowing, which may indicate esophageal irritation or ulceration — take with plenty of water and remain upright (see Precautions and Warnings)
• Severe headache, blurred or double vision, or vision loss, which may indicate intracranial hypertension (pseudotumor cerebri)
• Yellowing of the skin or eyes, dark urine, or unusual tiredness, which may indicate liver injury
• Severe or persistent watery/bloody diarrhea, which may indicate Clostridioides difficile-associated diarrhea or colitis
• Signs of a severe allergic reaction such as swelling of the face/throat, hives, or difficulty breathing
• Unusual bruising or bleeding, which may rarely indicate a blood disorder

Pregnancy

Renamycin is contraindicated in pregnancy. Use of Renamycin during the second and third trimesters, when fetal teeth and bones are developing, is well established to cause permanent discoloration of the teeth (yellow-gray-brown staining) and enamel hypoplasia, and may inhibit fetal bone growth. Because of this well-documented, class-wide risk, Renamycin should not be used in pregnant women; a physician should be consulted so that an alternative antibiotic can be selected. Any inadvertent exposure to Renamycin during pregnancy should be discussed promptly with a physician.

Breastfeeding

Renamycin passes into breast milk. Because of the risk of tooth discoloration and effects on bone growth in the nursing infant, Renamycin should be avoided during breastfeeding; a physician should be consulted so that an alternative antibiotic considered safer in lactation can be used if antibiotic therapy is required.

• Tooth discoloration and bone growth effects (children and pregnancy): Renamycin, like other tetracyclines, causes permanent tooth discoloration and enamel hypoplasia when used during tooth development (second half of pregnancy, infancy, and childhood up to about 8 years), and may inhibit bone growth in the fetus and young children; this is a well-established, class-wide effect and is the basis for the contraindication in pregnancy and in children under 8 years — see Contraindications.
• Photosensitivity: Renamycin can cause an exaggerated sunburn-like skin reaction; use sun protection and limit sun/UV exposure while taking Renamycin.
• Esophageal irritation and ulceration: take Renamycin with plenty of water, remain upright afterward, and avoid bedtime dosing.
• Hepatotoxicity: rare but serious liver injury (including fatty liver/hepatic failure) has been reported with Renamycin, particularly with high doses, intravenous administration, pregnancy, or pre-existing renal or hepatic impairment; use with caution and monitor liver function in at-risk patients.
• Renal impairment: Renamycin accumulates in patients with reduced kidney function and can increase azotemia and worsen renal impairment; Renamycin should be used with caution, at reduced frequency, and with monitoring of renal function in such patients, or an alternative antibiotic should be considered.
• Intracranial hypertension (pseudotumor cerebri): tetracycline-class drugs including Renamycin have been associated with raised intracranial pressure, more often in women of childbearing age; symptoms include severe headache and visual disturbance. Discontinue Renamycin promptly if this occurs.
• Superinfection: prolonged use of Renamycin may lead to overgrowth of non-susceptible organisms, including fungal infections and C. difficile-associated diarrhea; report new symptoms to a healthcare professional.
• Antibiotic stewardship: take Renamycin exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice, as inappropriate use of Renamycin promotes antibiotic resistance.
• Not effective against viral infections: Renamycin treats bacterial infections only and has no effect on viruses such as those causing the common cold or influenza.

Reported effects of Renamycin overdose are generally an extension of its known side effects, particularly gastrointestinal upset (nausea, vomiting, diarrhea) and esophageal or gastric irritation. No specific antidote for Renamycin overdose exists. If an overdose of Renamycin is suspected, seek immediate medical attention or contact emergency services or a poison control center right away; do not attempt specific home treatment. Management of Renamycin overdose is generally supportive and symptomatic, guided by a physician; Renamycin is not significantly removed by hemodialysis.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Children

Renamycin is contraindicated in children under 8 years of age for routine use, due to the well-established risk of permanent tooth discoloration, enamel hypoplasia, and effects on bone growth (see Contraindications). In children over 8 years, Renamycin may be used when clearly indicated, at a weight-based dose of 15–25 mg/kg/day in divided doses, not exceeding the usual adult dose.

Elderly

No specific dose adjustment of Renamycin is established for older adults on the basis of age alone, but renal function should be assessed before and during treatment, since Renamycin accumulates in renal impairment, which is more common in this age group.

Renal Impairment

Renamycin is eliminated substantially by the kidneys and accumulates in patients with reduced renal function, which can worsen azotemia and increase the risk of toxicity; Renamycin should be used with caution, at a reduced dosing frequency, and with monitoring of renal function, or an alternative antibiotic not dependent on renal clearance should be considered in significant renal impairment.

Hepatic Impairment

Renamycin should be used with caution in patients with hepatic impairment, since tetracyclines including Renamycin have been associated with hepatotoxicity, particularly at higher doses; dose reduction and liver function monitoring are advised.

Pregnant and Breastfeeding Women

See the Pregnancy and Lactation section above; Renamycin is contraindicated in pregnancy and should be avoided during breastfeeding.

The duration of treatment with Renamycin is set by the prescriber and depends on the indication: commonly 7–14 days for uncomplicated bacterial and rickettsial infections (continuing at least 24–48 hours after fever resolves for rickettsial disease), 3 weeks in combination therapy for brucellosis, and 15–30 days as alternative therapy for syphilis depending on stage. For acne, courses of Renamycin are typically limited and periodically reassessed rather than continued indefinitely, consistent with antibiotic stewardship. Patients should take Renamycin for exactly as long as prescribed and should not stop, extend, skip doses, or repeat a course without medical advice.

Tetracycline-class antibiotic

Oxytetracycline is a bacteriostatic antibiotic. Oxytetracycline binds reversibly to the 30S ribosomal subunit of susceptible bacteria, blocking the binding of aminoacyl-tRNA to the mRNA-ribosome complex. This prevents addition of amino acids to the growing peptide chain, inhibiting bacterial protein synthesis and thereby arresting bacterial growth and multiplication without directly killing the organism. Oxytetracycline is active against a broad range of Gram-positive and Gram-negative bacteria as well as rickettsiae, mycoplasma, and chlamydiae.

D

Renamycin is contraindicated in children under 8 years of age for routine use because of the well-established risk of permanent tooth discoloration, enamel hypoplasia, and inhibition of bone growth that occurs when tetracyclines are used during the period of tooth and bone development. In children over 8 years, when a tetracycline is clearly indicated and no suitable alternative exists, Renamycin may be dosed at 15–25 mg/kg/day in equally divided doses every 6 hours, not exceeding the usual adult dose. Safety and efficacy of Renamycin in neonates and infants have not been established, and use in this age group is not recommended outside exceptional, physician-directed circumstances. Any pediatric use of Renamycin should be guided by a pediatrician weighing the specific indication, the child's age, and the availability of alternative antibiotics.