Purbac: Uses, Indications,Dosage,Side Effects, and More

PURBAC is classified under Schedule 4 (S4), which means it requires a prescription for use.

Purbac is an antibiotic containing sulfamethoxazole and trimethoprim, used to treat bacterial infections such as urinary tract infections, respiratory infections, and certain types of gastrointestinal infections. It is typically taken orally, with dosage varying based on the condition being treated.

PURBAC is available in the following dosage forms:

• PURBAC ADULT (Tablet)
• PURBAC DOUBLE STRENGTH (Tablet)
• PURBAC PAEDIATRIC SUSPENSION

Composition

PURBAC ADULT (Tablet)

• Active Ingredients:
  • Trimethoprim: 80 mg
  • Sulphamethoxazole: 400 mg
• Excipients: Hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, Nipastat, pregelatinised starch, sodium starch glycolate, starch maize
• Preservative: Nipastat 0.02% m/m
• Sugar-Free

PURBAC DOUBLE STRENGTH (Tablet)

• Active Ingredients:
  • Trimethoprim: 160 mg
  • Sulphamethoxazole: 800 mg
• Excipients: Same as PURBAC ADULT
• Preservative: Nipastat 0.02% m/m
• Sugar-Free

PURBAC PAEDIATRIC SUSPENSION

• Active Ingredients:
  • Trimethoprim: 40 mg per 5 ml
  • Sulphamethoxazole: 200 mg per 5 ml
• Excipients: Aluminium magnesium silicate, aniseed oil, carmellose sodium, erythrosine powder (C.I. 45430), ethanol, Nipastat, polysorbate, purified water, sodium cyclamate, sucrose
• Preservative: Nipastat 0.3% m/v
• Contains Sugar: 3 g sucrose per 5 ml
• Contains Sweetener: Sodium cyclamate 20 mg

Category and Pharmacological Class

• Category: A 20.2 (Antimicrobial agents, excluding antibiotics)
• Mechanism of Action: PURBAC exhibits bactericidal properties through inhibition of folinic acid synthesis in bacteria, making it effective against a wide range of infections.

Indications

PURBAC is used to treat various infections, including:

Respiratory Tract Infections:

• Bronchitis
• Sinusitis
• Tonsillitis
• Pneumonia (including Pneumocystis jirovecii pneumonia)
• Otitis media

Renal and Urinary Tract Infections:

• Cystitis
• Pyelitis
• Pyelonephritis
• Urethritis
• Prostatitis

Gastrointestinal Infections:

• Enteritis
• Typhoid
• Paratyphoid
• Bacillary dysentery
• Cholera

Genital Infections:

• Gonorrhea
• Bacterial infections in both males and females

Skin and Soft Tissue Infections:

• Pyoderma
• Boils
• Furuncles
• Abscesses

Other Bacterial Infections:

• Brucellosis
• Nocardiosis
• Osteomyelitis

Contraindications

PURBAC should not be used in patients with:

• Porphyria, liver damage, or severe renal insufficiency
• Megaloblastic anemia (due to folic acid deficiency)
• Hypersensitivity to sulphonamides or trimethoprim
• Pregnancy and breastfeeding
• Premature or newborn infants (first few weeks of life)

Use During Pregnancy and Breastfeeding

• During pregnancy: Contraindicated (risk of congenital defects and kernicterus in the fetus).
• During breastfeeding: Contraindicated (enters breast milk, risk of jaundice in infants).

Effect on Fertility and Ability to Drive

• Effect on fertility: Insufficient data available.
• Effects on ability to drive and use machines: May cause dizziness and weakness; caution is advised.

Warnings and Precautions

• Higher risk of side effects in immunocompromised patients (AIDS, immunosuppressive therapy)
• Possible severe allergic reactions such as erythema multiforme, toxic epidermal necrolysis, and allergic vasculitis
• Caution required in folate-deficient patients, elderly individuals, and those on pyrimethamine therapy
• Risk of blood disorders and thrombocytopenia, especially in elderly patients taking diuretics
• Renal function monitoring recommended in patients with kidney disease
• Adequate fluid intake necessary to prevent crystalluria

Drug Interactions

PURBAC may interact with various medications, including:

Drug Class	Interaction Effect
Anticoagulants (Warfarin)	Enhanced anticoagulant effect
Methotrexate & Phenytoin	Increased drug toxicity
Diuretics (Thiazides)	Increased risk of thrombocytopenia
Oral Hypoglycemic Agents	Potentiation of hypoglycemic effects
Digoxin, Procainamide, Tolbutamide	Increased drug levels due to decreased clearance

Dosage and Administration

Standard Dosage

Age Group	Dosage
Children (6-12 years)	1 PURBAC ADULT tablet every 12 hours
Adults & Children (>12 years)	2 PURBAC ADULT tablets or 1 PURBAC DOUBLE STRENGTH tablet every 12 hours
Severe Cases	3 PURBAC ADULT tablets or 1.5 PURBAC DOUBLE STRENGTH tablets every 12 hours
Long-term Treatment	1 PURBAC ADULT or 0.5 PURBAC DOUBLE STRENGTH tablet every 12 hours

Paediatric Dosage (Suspension)

• Children (6-12 years): 10 ml twice daily (shake bottle before use)
• Duration: Minimum of 5 days or 2 days post-symptom relief
• If no improvement after 7 days, reassessment is necessary

Renal Impairment Dosage Adjustments

Creatinine Clearance	Dosage
> 25 ml/min	Standard dosage
15-25 ml/min	Standard for 3 days, then half dosage
< 15 ml/min	Not recommended unless on dialysis

Side Effects

Common Side Effects:

• Skin rash
• Nausea, vomiting, diarrhea
• Headache, dizziness, insomnia, fatigue

Severe Adverse Reactions:

• Allergic reactions: Anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis
• Hematologic disorders: Aplastic anemia, agranulocytosis
• Renal issues: Crystalluria, renal failure
• Neurological effects: Peripheral neuritis, optic neuropathy
• Gastrointestinal disturbances: Pancreatitis, pseudomembranous colitis

Overdose Management

• Symptoms: Severe nausea, vomiting, confusion, blood disorders
• Treatment: Supportive care, hydration, folinic acid for severe cases

Storage and Presentation

• Storage: Keep below 25°C, protect from moisture and light
• Packaging: Available in various blister packs, bottles, and suspension forms
• Keep out of reach of children