Maryclantin: Uses, Dosage, Side Effects and Composition

Description and Composition of Maryclantin

Maryclantin is an antibiotic containing as its active pharmaceutical ingredient, Amoxicillin
and Clavulanic Acid, a b-lactamase inhibitor. It also contains inactive ingredients called excipients in sufficient quantities. Amoxicillin has a broad
spectrum of bactericidal activity against many Gram-positive & Gram-negative
microorganisms but it is susceptible to degradation by b-lactamases and
therefore the spectrum of activity does not include microorganisms, which
produce these enzymes. Clavulanic acid possesses the ability to inactivate a
wide range of b-lactamase enzymes commonly found in microorganisms
resistant to penicillins and cephalosporins. Thus Clavulanic acid in
combination of Amoxicillin and Clavulanic acid protects Amoxicillin from
degradation by b-lactamase enzymes and effectively extends the antibiotic
spectrum to embrace a wide range of microorganisms.

Indication and Usage of Maryclantin

Maryclantin is indicated for short-term treatment of bacterial infections at the
following sites:

  1. Upper respiratory tract infections (including ENT); e.g., tonsillitis, sinusitis, otitis media.
  2. Lower respiratory tract infections; e.g., acute and chronic bronchitis, lobar and bronchopneumonia.
  3. Genito-urinary tract infections; e.g., cystitis, urethritis, pyelonephritis.
  4. Skin and soft tissue infections.
  5. Boneand joint infections; e.g., osteomyelitis.
  6. Other infections; e.g., septic abortion, puerperal sepsis, intra-abdominal sepsis, etc.

Dosage and Administrations of Maryclantin

Dose of Tablets

Adults and children over 12 years:

The usual adult dose is one Amoxicillin clavulanic acid 625 Tablet every 12 hours or one Amoxicillin clavulanic acid 375 Tablet every 8 hours.

For more severe infections and infections of the respiratory tract, the dose should be one Amoxicillin clavulanic acid 1 g Tablet every 12 hours or one Amoxicillin clavulanic acid 625 Tablet every 8 hours.

Dose of Powder for Suspensions

Amoxicillin clavulanic acid Powder for Suspension:

Neonate: 0.25 ml/kg 3 times daily.

1 month–1 year: 0.25 ml/kg 3 times daily, dose doubled in severe infection.

1–6 years: 5 ml 3 times daily or 0.25 ml/kg 3 times daily, dose doubled in severe infection.

6–12 years: 10 ml 3 times daily, dose doubled in severe infection.

Amoxicillin clavulanic acid bid Powder for Suspension:

2 month-2 years: 0.15 ml/kg twice daily, doubled in severe infection.

2-6 years (13-21 kg): 2.5 ml twice daily, doubled in severe infection.

7-12 years (22-40 kg): 5 ml twice daily, doubled in severe infection.

12-18 years (over 40 kg): 10 ml twice daily, three times daily in severe
infection.

Dose of Injections:

Adults

Usually 1.2 g every 8 hours, increased in more severe infections to 1.2 g
every 6 hours.

Adult dosage for surgical prophylaxis

The usual dose is 1.2 g at induction, for high risk procedures, up to 2-3 further doses of 1.2 g may be given every 8 hours.

Children

0 to 3 months: 30 mg/kg every 8 hours (every 12 hours in the perinatal period
and in premature infants).

3 months to 12 years: Usually 30 mg/kg every 8 hours increased in more serious infections to 30 mg/kg every 6 hours.

Precautions

Maryclantin should be used with care in patients on anti-coagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal
impairment, dosage should be adjusted.

During the administration of high
dose of Amoxicillin Clavulanate adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.

Contraindications of Maryclantin

  • History of Penicillin hypersensitivity. Attention should be paid to possible cross sensitivity with other beta-lactam antibiotics.
  • Also contraindicated for patients with previous history of amoxicillin clavulanic acid or penicillin associated cholestatic jaundice.

Side Effects of Maryclantin

Side effects, as with Amoxicillin, are uncommon and mainly of a mild and
transitory nature.

  • Diarrhoea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported. If gastrointestinal side effects
    occur with oral therapy, that may be reduced by taking amoxicillin clavulanic acid at the start of meals.
  • Hepatitis and cholestatic jaundice have been reported rarely but are
    usually reversible.
  • Urticarial and erythematous rashes sometimes occur.
  • Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative
    dermatitis have been reported.
  • In common with other beta-lactam antibiotics angioedema and anaphylaxis have been reported.

Use of Maryclantin in Pregnancy and Lactation

Maryclantin has been used orally in human pregnancy in a
limited number of cases with no untoward effect; however use of amoxicillin clavulanic acid in pregnancy is not recommended unless considered essential by the physician.

During lactation, trace quantities of Amoxicillin can be detected in breast milk.

Drug Interactions with Maryclantin

  • Prolongation of bleeding time and prothrombin time has been reported in
    some patients receiving amoxicillin clavulanic acid.
  • In common with other broad-spectrum
    antibiotics, amoxicillin clavulanic acid may reduce the efficacy of oral contraceptives and patient should be warned accordingly.
  • Concomitant use of allopurinol during treatment with Amoxicillin can increase the likelihood of allergic skin reactions.
  • There are no data on the concomitant use of amoxicillin clavulanic acid with allopurinol.

Direction for Reconstitution of Maryclantin Powder for Injection and Oral Suspension

For preparation of 100 ml Suspension:

Shake the bottle to loosen powder. Add 95 ml of boiled and cooled water to
the dry powder. Pure table Water can be used equally for reconstitution.

For ease of preparation, add water to the bottle in two
portions. Shake well after each addition until all the powder is in suspension.

For preparation of 50 ml bid Suspension:

Shake the bottle to loosen powder. Add 43 ml of boiled and cooled water to
the dry powder. For ease of preparation, add water to the bottle in two
portions. Shake well after each addition until all the powder is in suspension.

Reconstitution Information for Injection:

Amoxicillin clavulanic acid 1.2 IV injection can be reconstituted by dissolving the powder in 20 ml Water for Injection BP.

Amoxicillin clavulanic acid 0.6 IV injection can be reconstituted by dissolving the powder in 10 ml Water for Injection BP.

Overdosage of Maryclantin

Problems of overdose with Maryclantin are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte
balances may be evident. Amoxicillin Clavulanic acid may be removed from the circulation by haemodialysis.

Pharmaceutical Precautions

For tablet 

Keep in a cool and dry place, below 25o C. Protect from light.

For suspension 

Keep the bottle tightly closed. The reconstituted suspension should be stored
in a cool place preferably in a refrigerator and use within 7 days of reconstitution.

For injection 

Use within 20 minutes of reconstitution, do not freeze. Not for intramuscular
use. Keep in a cool and dry place. Protect from light.

 

References 

  1. RxList
  2. MedlinePlus
  3. Medicine Net
  4. MSF Medical Guidelines

 

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