VULGA XR Tablets / Extended Release
Minocycline
80mg
HIKMA PHARMACEUTICALS LLC
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | Gulf Drug L.L.C. |
| Retail Price | 110.50 AED |
Indications
VULGA XR Tablets / Extended Release is used for:
Susceptible infections, Acne, Asymptomatic meningococcal carriers, Uncomplicated gonorrhoea, Nongonococcal urethritis, Syphilis,
Adult Dose
Oral
Susceptible infections
Adult: 200 mg daily in divided doses.
Acne
Adult: 50 mg bid or 100 mg once daily. ?45 kg: 1 mg/kg once daily as modified-release preparation.
Asymptomatic meningococcal carriers
Adult: 100 mg bid for 5 days, followed by a course of rifampicin.
Nongonococcal urethritis
Adult: 100 mg 12 hrly for at least 7 days.
Uncomplicated gonorrhoea
Adult: Initially, 200 mg, followed by 100 mg 12 hrly for a min of 4 days, follow-up cultures should be done w/in 2-3 days after completion of therapy.
Uncomplicated urethral gonorrhoea in men
Adult: 100 mg 12 hrly for 5 days.
Mycobacterium marinum infections
Adult: 100 mg 12 hrly for 6-8 wk.
Syphilis
Adult: 200 mg initially, followed by 100 mg 12 hrly for 10-15 days.
Intravenous
Susceptible infections
Adult: Initially, 200 mg followed by 100 mg 12 hrly. Max: 400 mg/day.
Child Dose
Intravenous
Susceptible infections
Child: >8 yr Initially, 4 mg/kg, then 2 mg/kg 12 hrly not to exceed the usual adult dose.
Oral
Acne Vulgaris
<12 years: Safety and efficacy not established
Immediate-release products: 4 mg/kg PO initially (not to exceed 200 mg), THEN 2 mg/kg/day PO q12hr; not to exceed 400 mg/day
Extended-release tablets: 1 mg/kg PO qDay
Administer therapy for 12 weeks
Renal Dose
Renal impairment: Reduce dose or increase dosing interval. Max: 200 mg/day.
Administration
IV Preparation
Reconstitute cryodessicated powder with 5 mL sterile water for injection
Immediately dilute further with 500-1000 mL of 0.9% NaCl, dextrose solutions, dextrose and NaCl solutions, Ringer Injection, or Lactated Ringer
Reformulated Minocin IV
Allows for dilution with lower fluid volume
After vial reconstitution, dilute further with 100-1000 mL of 0.9% NaCl, dextrose solutions, dextrose and NaCl solutions, or 250-1000 mL of Ringer or Lactated Ringer injections
IV Administration
Avoid rapid IV infusion
Infuse over one hour
Not to exceed 400mg in 24 hours
Oral Administration
May take with or without food
Ingestion of food along with may help reduce the risk of esophageal irritation and ulceration
Extended-release tablets or capsules: Swallow whole without chewing, crushing, or splitting
Extended-release tablet: These tablets are scored and intended to split to give precise dose
Contra Indications
Documented hypersensitivity
Precautions
Caution in significant renal impairment (may lead to azotemia, hyperphosphatemia, and acidosis; monitor BUN)
Adjust dose if renal impairment occurs
Anaphylaxis reported; discontinue use and institute supportive therapy
Prolonged use may result in fungal or bacterial superinfection
Lupus, hepatitis, and vasculitis autoimmune syndromes reported with use; discontinue if lupus symptoms occur and assess liver function tests; ANA and CBC
Discontinue therapy if pseudomembranous colitis occurs
Risk of vestibular reactions
Caution in hepatic impairment; discontinue if liver injury occurs
Photosensitivity may occur with prolonged exposure to sunlight or tanning equipment; use skin protection and avoid prolonged exposure to sunlight
Reduce dose in renal impairment; consider drug serum level determinations in prolonged therapy
Tetracycline use during tooth development (last half of pregnancy through age 8 years) can cause tooth enamel hypoplasia or permanent teeth discoloration; more common with long-term use and with repeated, short courses; during pregnancy, may retard skeletal development and reduce bone growth
Fanconi-like syndrome may occur with outdated tetracyclines
Lightheadedness and vertigo may occur; use caution when performing tasks that require mental alertness or operating heavy machinery
May increase BUN secondary to antianabolic effects
Cases of drug rash with eosinophilia and systemic symptoms (DRESS) reported, some fatal; discontinue immediately
Pregnancy-Lactation
Pregnancy category: D
Lactation: Enters breast milk, some manufacturers say do not nurse; however AAP considers nursing compatible due to calcium chelation of drug and prevention of its absorption; long-term safety of prolonged exposure unknown
Interactions
Impaired absorption by concomitant admin w/ Ca-containing antacids and other divalent or trivalent cations (e.g. Al, bismuth, Fe, Mg, Zn). May decrease effectiveness of oral contraceptives. May interfere w/ the bactericidal action of penicillins. May potentiate the effect of anticoagulants. Increased risk of nephrotoxicity w/ diuretics. Increased risk of pseudotumour cerebri w/ retinoids (e.g. isotretinoin). Increased risk of ergotism w/ ergot alkaloids.
Potentially Fatal: Concurrent use w/ methoxyflurane may result to fatal renal toxicity.
Adverse Effects
Side effects of Minocycline :
Discoloration of teeth (in children)
Vestibular symptoms (>30%)
Pericarditis
Myocarditis
Vasculitis
Angioedema
Alopecia
Erythema nodosum
Erythematous rash
Exfoliative dermatitis
Pruritus
Toxic epidermal necrolysis
Urticaria
Dizziness
Fever
Fatigue
Somnolence
Angioedema
Hyperpigmentation of nails
Pigmentation of skin and mucous membranes
Thyroid dysfunction
Thyroid discoloration
Thyroid cancer
Vulvovaginitis
Hemolytic anemia
Neutropenia
Thrombocytopenia
Agrunolocytosis
Pancytopenia
Hepatic cholestasis
Hepatitis
Hyperbilirubinemia
Jaundice
CNS effects
Clostridium difficile diarrhea
Mechanism of Action
Minocycline inhibits protein synthesis by binding to 30S and possibly 50S ribosomal subunits of susceptible bacteria. It is active against Streptococcus aureus, Neisseria meningitidis, various enterobacteria, Acinetobacter, Bacteroides, Haemophilus and Nocardia spp., and some mycobacteria.
Note
VULGA XR 80mg Tablets / Extended Release manufactured by HIKMA PHARMACEUTICALS LLC. Its generic name is Minocycline. VULGA XR is availble in United Arab Emirates.
Farmaco UAE drug index information on VULGA XR Tablets / Extended Release is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
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