Roal

Uses

Roal is used for the treatment of infections caused by susceptible microorganisms;

Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia

ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.

Skin infections like folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo and infected dermatitis.

Genital infections like urethritis, prostatitis, cervicitis and salpingitis especially if produced by Chlamydia trachomatis.

Roal, is a macrolide with antibacterial properties similar to erythromycin. It is active against Gram-positive bacteria like staphylococci, streptococci, listeria, corynebacteria; Gram-negative bacteria such as gonococci, Haemophilus influenzae, Haemophilus ducreyi, Legionella, campylobacter, and atypical pathogens like Mycoplasma and Chlamydia. Roal has been found useful in the treatment of upper and lower respiratory tract infection, otorhinolaryngological, skin, dental and genital infections. It is well tolerated by adults and children.

Roal is also used to associated treatment for these conditions: Lower Respiratory Tract and Lung Infections, Respiratory Tract Infections (RTI), Skin Infections, Ear, nose, and throat infections

How Roal works

Roal prevents bacterial growth by interfering with their protein synthesis. It binds to the 50S subunit of bacterial ribosomes and inhibits the translocation of peptides.

Dosage

Roal dosage

Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roal is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.

Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed

• 6 to 11 Kg: 25 mg Roal 12 hourly.
• 12 to 23 Kg: 50 mg Roal 12 hourly.
• 24 to 40 Kg: 100 mg Roal 12 hourly.

A normal course of therapy is between 5 and 10 days.

Side Effects

Roal is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.

Toxicity

Roal primarily causes gastrointestinal adverse events, such as diarrhoea, nausea, abdominal pain and vomiting. Less common adverse events include headaches, rashes, abnormal liver function values and alteration in senses of smell and taste.

Precaution

Roal should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roal should not exceed 150 mg twice a day.

Interaction

Roal does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roal shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roal.

Elimination Route

Very rapidly absorbed and diffused into most tissues and phagocytes.

Half Life

12 hours

Pregnancy & Breastfeeding use

The safety of Roal in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.

Contraindication

Roal should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.

Innovators Monograph

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