VULGA XR 105/MG ER TAB 30/TAB

Indications

Approved Uses

Inflammatory lesions of non‑nodular moderate to severe acne vulgaris (oral minocycline XR).

Dosage & Administration

Dosing by Condition

Acne vulgaris (XR): weight‑based ~1 mg/kg orally once daily for 12 weeks (e.g., 105 mg once daily is a common fixed strength for appropriate weight bands).

Initial Dose

Approximately 1 mg/kg once daily, based on patient weight. For a patient weighing 97-110 kg, the dose is 105 mg once daily.

Maintenance Dose

Approximately 1 mg/kg once daily.

Maximum Dose

For this product (minocycline prolonged‑release 105 mg tablet): maximum is 105 mg once daily (do not exceed 1 tablet/day).

Children's Dosage

Safety and effectiveness in pediatric patients below the age of 12 years have not been established. The recommended dosage of Minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily.

Dose Adjustment Notes

No routine dose adjustment is required for mild-moderate renal impairment, but in significant renal impairment use caution and consider reducing total daily dose/interval; use caution in hepatic impairment and with prolonged therapy.

How to Take

Swallow the prolonged‑release (XR) tablet whole with a full glass of water; do not crush, chew, or split; may be taken with or without food; take at the same time each day; take while upright and avoid lying down for at least 30 minutes after the dose.

Side Effects

Common Side Effects

Dizziness/vertigo, headache, nausea, vomiting, diarrhea, fatigue, and skin rash/photosensitivity; less common but notable with minocycline are hyperpigmentation and (with prolonged use) vestibular effects.

Side Effect Frequency

Common: dizziness/vertigo (vestibular effects), nausea, diarrhea, headache; less common/uncommon: photosensitivity and skin hyperpigmentation, tinnitus; rare/very rare but serious: intracranial hypertension, severe cutaneous adverse reactions (e.g., SJS/TEN), hypersensitivity reactions, and autoimmune syndromes (drug-induced lupus/autoimmune hepatitis).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to minocycline/other tetracyclines; pregnancy (avoid-particularly after mid‑pregnancy); concomitant systemic retinoids (e.g., isotretinoin) due to intracranial hypertension risk.

Age Restriction

Not recommended in children <8 years; for acne, minocycline ER (105 mg) is generally indicated for patients ≥12 years (adolescents and adults).

Drug Interactions

Drug Interactions

Key interactions: polyvalent cations (Al/Mg/Ca antacids, iron, zinc, bismuth) reduce absorption-separate dosing; isotretinoin/other systemic retinoids increase intracranial hypertension risk-avoid; warfarin/anticoagulants may have increased effect-monitor INR; penicillins may be antagonized; methoxyflurane (if used) increases nephrotoxicity risk; hormonal contraceptives-counsel about possible reduced efficacy/backup if vomiting/diarrhea or per local policy.

Interaction Severity

MAJOR: systemic retinoids (e.g., isotretinoin) due to additive risk of intracranial hypertension; methoxyflurane due to nephrotoxicity. MODERATE: warfarin/anticoagulants (↑ anticoagulant effect-monitor INR), penicillins (possible antagonism), oral contraceptives (possible reduced efficacy/backup advised), and chelators (antacids/iron/calcium/magnesium/zinc) causing reduced absorption (manage by separation).

Food Interaction

XR minocycline may be taken with or without food; avoid taking with (or separate by at least 2 hours from) antacids or supplements containing aluminum, magnesium, calcium, iron, or zinc, and avoid concurrent dairy/mineral-fortified products if they contain significant polyvalent cations.

Special Populations

Pregnancy

Contraindicated

Children

Safety and effectiveness in pediatric patients below the age of 12 years have not been established. The recommended dosage of Minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily.

Elderly

Standard adult dosing; use with caution due to increased risk of vestibular side effects and potential renal impairment; monitor renal and hepatic function

Storage & Patient Advice

Stopping the Medicine

Do not stop early for infections; complete the prescribed course unless significant adverse effects occur. For acne, reassess response after ~12 weeks and discontinue if ineffective or once adequate control is achieved per prescriber plan.

Patient Counseling

Swallow XR tablet whole (do not crush/chew); take with a full glass of water and avoid lying down for 30 minutes; may take with food if GI upset; separate from antacids/iron/calcium (and dairy) by at least 2 hours; avoid excessive sun and use sunscreen; complete the prescribed course; seek care for severe headache/visual changes (intracranial hypertension), severe rash, or hypersensitivity; may cause dizziness-use caution driving; avoid in pregnancy.

Pharmacology

Mechanism of Action

Binds reversibly to the 30S ribosomal subunit to inhibit bacterial protein synthesis (blocks aminoacyl‑tRNA attachment), producing a primarily bacteriostatic effect.

Onset of Action

Antibacterial activity begins within hours after dosing; for acne, noticeable clinical improvement is typically seen after ~6-8 weeks (maximal benefit by ~12 weeks).

Duration of Effect

Approximately 24 hours per dose (once‑daily coverage) for the XR formulation; clinical effects persist only while therapy is continued.

Half-Life

11-22 hours.

Bioavailability

90-100%

Metabolism

Hepatic metabolism occurs to some extent, but minocycline is not extensively CYP450-mediated; a significant portion is eliminated unchanged (mainly via bile/feces).

Excretion

Primarily non-renal (fecal/biliary) elimination with a smaller renal component; approximate figures commonly cited are fecal ~20-35% and urinary ~5-15%.

Protein Binding

76%

Product Information

Available Dosage Forms

Minocycline is available (globally) as immediate‑release capsules/tablets and as extended/prolonged‑release tablets; some markets also have oral suspension and IV injection (minocycline), while topical foam is a separate topical minocycline product and not interchangeable with oral XR.

Composition per Dose

Each extended-release film-coated tablet: 105 mg minocycline (as minocycline hydrochloride)

Generic Availability

Yes

Spectrum

Broad-spectrum.

Antibiotic Class

Tetracycline

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 10-06-2026