Nomika

Nomika

minocycline

Manufacturer:

Ikapharmindo
Full Prescribing Info
Contents
Minocycline HCl.
Description
NOMIKA 50: Each capsule contains Minocycline HCl equivalent to Minocycline 50 mg.
NOMIKA 100: Each capsule contains Minocycline HCl equivalent to Minocycline 100 mg.
Action
Pharmacology: Minocycline is a semisynthetic antibiotic Tetracyclines of the first available in 1972. Like other Tetracyclines, it has a broad spectrum of activity. Besides having an antibiotic activity, Minocycline also has chelating agent activity and form a chelate with Ca2+, Mg2+, or Al3+ ions in the intestine.
The main mechanism of its activity on protein synthesis: Minocycline is more lipophytic compare to other Tetracyclines and can penetrate directly through the layer of fat on the bacterial cell wall. Energy dependens on pump activity of the drug transport system, like all Tetracyclines are through the inner membrane cytoplasmin. In bacterial cells, Minocycline inhibits protein synthesis by forming ties with the 30S ribosome. Drugs seem to prevent the entry of aminoacyl tRNA to the acceptor in the mRNA ribosome complex. Prevention is to add amino acids to the growth of peptide chains. Minocycline will inhibit protein synthesis in mammalian cells when used at very high concentrations.
Indications/Uses
For infections caused by Rickettsia (Rocky Mountain spotted fever, Typhoid fever and Typhus group, Q Fever, Rickettsialpox, Tick Fever), Pneumonial mycoplasma (PPLO, Eaton agent), Psittacosis and Omithosis agent, Lymphogranuloma venereum and granuloma inguinal agent, Spirochaetal agent of Relapsing Fever (Borrelia recurrentis).
Gram-negative microorganisms: Haemophilus ducreyi, Pasteurella pestis and Pasteurella tularensis, Bartonella bacilliformis, Bacteroides species, Vibrio comma and Vibrio fetus, Brucella species (in conjunction with Streptomycin). Because some strains of microorganisms group showed resistancy to Tetracyclines, it is recommended culture and susceptibility tests.
Treatment of infections caused by gram-positive microorganisms when bacteriological testing indicates appropriate susceptibility to the drug.
Streptococcus species: up to 44% of Streptococcus spyrogenes strains and 74% of Streptococcus faecalis strains found to be resistant to Tetracycline drugs.
For treatment of Uncomplicated Gonococcal Urethritis in humans (men) due to Neisseria gonorrhoeae. When the Penicillin contraindicated, Tetracyclines are alternative medicines for the treatment of infections caused by Neisseria gonorrhoeae (in women), Treponema pallidum and Treponema pertennue (syphilis and yaws), Listeria monocytogenes, Clostridium species, Bacillus anthracis, Fusobacterium fusiforme (Vincent's Infection), Actinomyces species.
In acute intestinal amebiasis, Tetracyclines can be used as an adjunct to amoebicides.
In severe acne, Tetracyclines are used as additional therapy.
Minocyciine given orally is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy are linked, the limit of clinical data showed that Minocycline given orally used for the treatment of infections caused by Mycobacterium marinum.
Dosage/Direction for Use
Therapy should be continued for 24-48 hours after symptoms and fever are reduced. Antacids that contain the same therapeutic aluminium, calcium or magnesium interfere with absorption, and should not be given to patients who are given oral Tetracyclines.
For treatment of streptococcal infections, Tetracycline therapeutic doses given for at least 10 days.
Adults: 200 mg initial dose followed by 100 mg every 12 hours, other alternative if the frequency is more frequent 2-4 x 50 mg capsules as initial dose, followed by 50 mg 4 times daily.
Children above 8 years: 4 mg/kg body weight as the initial dose, followed by 2 mg/kg body weight every 12 hours.
For treatment of Syphilis: the initial dose is given over 10-15 days, the last followed by laboratory tests.
Patients with Gonorrhea who are sensitive to Penicillin, given Minocycline 200 mg as initial dose, followed by 100 mg every 12 hours, a minimum of 4 days with 2-3 days post-therapy culture.
In the treatment of Meningococcal carriers recommended dose of 100 mg every 12 hours for 5 days. In Mycobacterium marinum infections: although the optimal dose has not been determined, but in some cases successfully with 100 mg 2 times a day, for 6-8 weeks.
For treatment of Uncomplicaled Gonococcal Urethritis in males: 100 mg 2 times a day, for 5 days.
Contraindications
Hypersensitivity to Tetracyclines.
Pregnant women and nursing mothers.
Children under 12 years.
Systemic lupus erythematosus.
Patients with severe renal impairment.
Special Precautions
The use of drugs Tetracyclines during tooth growth (in the last half of pregnancy, infant, children under 8 years) may cause permanent tooth staining (yellow-grey). These side effects are more common during the use of drugs, but also repeated observations in the case of short-term treatment.
The existence of Enamel hypoplasia has also been reported, in kidney failure, usually either oral or parenteral doses.
Excessive growth can occur from the non-susceptible organisms, including fungi. If super infection occurs, discontinue treatment.
In the long-term therapy, periodic laboratory evaluation should be organ systems, including hematopoetic, kidneys and liver.
Other Effects: Tetracycline is reported to use an emergency, for anabolitic activities who was instrumental in increasing the concentration of urea in the blood.
Tetracycline also reduced plasma prothrombin activity by inhibiting the production of Vitamin K intestinal flora.
Interference with clinical pathology tests: Tetracycline can produce fluorescence in interferense Hungarty method to measure cerinary catecholamines, also reducing bacteria urobilinogen modifier bilirubin into the intestine.
High risk group: Pregnant women: Cause tooth staining in fetus.
Change the color of the teeth have been reported, but rarely in adults.
Breast milk: Tetracycline is not given as antibiotics through breast milk in children.
Neonates: Drug contraindicated because staining of teeth, enamel hypoplasia and suppress the growth of bone.
Children: Minocycline contraindicated for children under 12 years, with the same reasons as in neonates. For children over 12 years. 50 mg of Minocycline every 12 hours is recommended.
Elderly: Minocycline may be used at the normal recommended dosage in the elderly, even with mild to moderate renal impairment.
Use In Pregnancy & Lactation
Pregnant women: Cause tooth staining in fetus.
Change the color of the teeth have been reported, but rarely in adults.
Breast milk: Tetracycline is not given as antibiotics through breast milk in children.
Side Effects
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glositis, dysphagia, enterocolitis, pancreatitis, inflammation, lesions in anogenital region and liver enzyme elevations, rarely: hepatitis.
This reaction is caused by the use of either oral or parenteral.
Skin: Maculopapular and erythema, were also reported exfoliative dermatitis, but not common. Pigmentation of the skin and mucous membranes were also reported.
Hypersensitivity reactions: Urticaria, angioneurotic, edema, polyarthralgia, anaphylaxis, anaphylactic purpura, pericarditis, exacerbation of lupus erythematosus system and rarely pulmonary infiltration with eosinophilia.
CNS: When given for a long time, it was reported that Tetracyclines cause brown-black microscopic discoloration of thyroid gland. No abnormalities of thyroid function in the study. Vestibular disorders of Minocycline may cause dizziness, vertigo, ataxia; nausea and tinnitus, but its nature reversible. Preliminary studies indicate that vestibula dysfunction occurred in 4.5%-7.2% of patients, this disorder reversible 3-48 hours of therapy was not continued, and less when a low dose (50 mg 2 times a day).
Blood: Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia.
ONS: Pseudo-cerebral tumor (Benign lntracranial Hypertension) in adults and bulging fontanels in infants, headache have been reported.
Drug Interactions
Tetracycline can enhance methoxyflurane-induced nephrotoxicity. Sodium bicarbonate may inhibit Tetracyclines in the digestive tract by increasing the pH.
Minocycline reduce plasma prothrombin activity by inhibiting the production of Vitamin K in intestinal flora.
Antacids containing divalent and trivalent cations, which form a chelate with Tetracyclines, inhibits oral absorption. Cations are found in foods, especially everyday products, and iron preparations have the same effect.
Activities bacteriostatic Tetracycline can interfere with the activities bacterisid Penicillin.
Storage
Store in a dry place below 30°C.
ATC Classification
J01AA08 - minocycline ; Belongs to the class of tetracyclines. Used in the systemic treatment of infections.
Presentation/Packing
Cap 50 mg x 10 x 10's. 100 mg x 10 x 10's.
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