AA Pharma Minocycline Warnings

Newborns, Infants and Children: The use of tetracyclines, including minocycline, during tooth development (last half of pregnancy, infancy and childhood under the age of thirteen years) has been shown to cause permanent tooth discolouration (yellow-grey-brown). This is more common during long-term use, but has been observed following short-term courses. Enamel hypoplasia has also been reported. All tetracyclines including minocycline form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This appeared to be reversible when the drug was discontinued. Minocycline should not be used in such patients unless other drugs are ineffective or are contraindicated.
Pregnancy and Lactation: Tetracyclines, including minocycline, are not recommended during pregnancy and lactation because of possible adverse effects on developing bones and teeth of the fetus and neonate. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryo-toxicity has also been noted in animals treated early in pregnancy. The safety of minocycline for use during pregnancy has not been established.
Tetracyclines, including minocycline, are excreted in the milk of lactating women.
It is advisable to avoid giving minocycline in conjunction with penicillin since some bacteriostatic drugs may interfere with the bactericidal action of penicillin.
Minocycline should not be used for the treatment of streptococcal diseases unless the organism is demonstrated to be sensitive, since most streptococci have been found to be resistant to tetracycline drugs. If it is deemed necessary that infection due to Group A beta-hemolytic streptococci be treated with minocycline, then such treatment should be continued for at least ten days.
In the presence of significant renal impairment, usual oral doses may lead to excessive systemic accumulations of minocycline and possible liver toxicity. Under such conditions, lower than usual doses may be indicated. After initial therapy, and if therapy is prolonged, serum level determinations of the drug are advisable.
The anti-anabolic action of tetracyclines can also produce dose-related increased in BUN; consequently, in patients with significant renal impairment, elevated serum minocycline levels can lead to azotemia, hypophosphatemia and acidosis.
Minocycline is capable of aggravating the symptoms associated with lupus erythematosus. Therefore, caution should be taken when administering the drug to patients with this disease.
Minocycline has been shown to depress plasma prothrombin activity. Therefore patients who are on anticoagulant therapy should be monitored regularly and may require downward adjustment of their anticoagulant dosage.
Interference with vitamin K synthesis by micro-organisms in the gut has been reported.
Cross sensitization among the various tetracyclines is extremely common.
Pigmentation of skin, thyroid, bone and teeth have been reported occasionally in persons receiving minocycline usually for extended periods of time. The pigmentation may be irreversible.