Description
Tyclav® is an antibacterial combination consisting of the antibiotic Amoxicillin
and the b-lactamase inhibitor Clavulanic Acid. 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
Tyclav® 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. Bone and joint infections; e.g., osteomyelitis.
6. Other infections; e.g., septic abortion, puerperal sepsis, intra-abdominal
sepsis, etc.
Dosage and Administrations
Dose of Tablets
Adults and children over 12 years:
The usual adult dose is one Tyclav® 625 Tablet every 12 hours or one Tyclav®
375 Tablet every 8 hours. For more severe infections and infections of the
respiratory tract, the dose should be one Tyclav® 1 g Tablet every 12 hours or
one Tyclav® 625 Tablet every 8 hours.
Dose of Powder for Suspensions
Tyclav® 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.
Tyclav® 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 (e.g., colorectal
surgery) 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
Tyclav® 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 Tyclav® adequate fluid intake and urinary output should be maintained
to minimize the possibility of crystalluria.
Contraindications
History of Penicillin hypersensitivity. Attention should be paid to possible cross
sensitivity with other beta-lactam antibiotics e.g., cephalosporins. Also
contraindicated for patients with previous history of Tyclav® or penicillin
associated cholestatic jaundice.
Side Effects
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 Tyclav® 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. Indications
Specific indications:Â Primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism.
Pituitary TSH Suppression: In the treatment or prevention of various types of euthyroid goiters, subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), multinodular goiter and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Therapeutic Class
Pharmacology
Dosage & Administration
In order to avoid irregular absorption, Levothyroxine should be taken preferably at a fixed time on an empty stomach. Concomitant intake of food may decrease the absorption of Levothyroxine. Dosing must be individualized and adjustments to be made based on periodic assessment of the patient’s clinical response and laboratory parameters.
Adult Dosage:
Initial starting dose:Â 25-50 mcg/day, with gradual increments in dose at 6-8 week intervals, as needed. The Levothyroxine Sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.
In patients with severe hypothyroidism: Initial dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.
In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism: Levothyroxine Sodium dose should be titrated until the patient is clinically euthyroid and the serum free – T 4 level is restored to the upper half of the normal range.
For patients older than 50 years or for patients under 50 years of age with underlying cardiac disease: 1.7 mcg/kg/day.
TSH suppression: For thyrotropin-dependent well-differentiated thyroid cancer: Doses >2 mcg/kg/day may be given as a single dose to suppress TSH to <0.1 MIU/L. For benign nodules and nontoxic multinodular goitre: Target TSH is generally higher at 0.1-0.5 MIU/L for nodules and 0.5-1 MIU/L for multinodular goitre.
Pediatric Dosage:
Newborns: The recommended starting dose is 10-15 mcg/kg/day. A lower starting dose should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low (< 5 mcg/dL) or undetectable serum T 4 concentrations, the recommended initial starting dose is 50 mcg/day of Levothyroxine Sodium.
Infants and Children: In children with chronic or severe hypothyroidism, initial dose of 25 mcg/day with increments of 25 mcg every 2-4 weeks until the desired effect is achieved. Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.
Daily dose per kg body weight:
- 0-3 months: 10-15 mcg/kg/day
- 3-6 months: 8-10 mcg/kg/day
- 6-12 months: 6-8 mcg/kg/day
- 1-5 years: 5-6 mcg/kg/day
- 6-12 years: 4-5 mcg/kg/day
- >12 years but growth and puberty incomplete: 2-3 mcg/ kg/ day
- Growth and puberty complete: 1.7 mcg/kg/day
The dose should be adjusted based on clinical response and laboratory parameters.
Interaction
Contraindications
Side Effects
Adverse reactions associated with Levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdose. They include the following:
- General: Fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
- Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
- Musculoskeletal: Tremors, muscle weakness
- Cardiovascular: Palpitations, tachycardia, arrhythmias, increased pulse and blood pressure
- Respiratory: Dyspnea
- Gastrointestinal: Diarrhea, vomiting, abdominal cramps
- Dermatologic: Hair loss, flushing
Pregnancy & Lactation
Precautions
Overdose Effects
The signs and symptoms of overdose are those of hyperthyroidism – agitation, confusion, irritability, hyperactivity, headache, sweating, mydriasis, tachycardia, arrhythmias, tachypnoea, pyrexia, increased bowel movements and convulsions. Cerebral embolism, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion of Levothyroxine Sodium.
Treatment of Overdose: Levothyroxine Sodium should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. Treatment is symptomatic.
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