Novamoxin (Amoxicillin Trihydrate)

NOVAMOXIN®

Novopharm

Amoxicillin Trihydrate

Antibiotic

Action And Clinical Pharmacology: Amoxicillin exerts its bactericidal action by interfering with bacterial cell wall synthesis.

Indications And Clinical Uses: The treatment of infections due to susceptible strains of the following microorganisms: Gram-negative organisms: H. influenzae, P. mirabilis and N. gonorrhea. Gram-positive organisms: streptococci (including S. faecalis and S. pneumoniae).

Amoxicillin is not active against P. aeruginosa, indole-positive Proteus species, S. marcescens, Klebsiella and Enterobacter species.

In emergency cases, where the causative organism is not yet identified, therapy may be initiated with amoxicillin on the basis of clinical judgment while awaiting bacteriologic tests to determine its antimicrobial sensitivity.

Amoxicillin may be indicated as a prophylaxis against alpha-hemolytic (Viridan’s group) Streptococci before dental, oral or upper respiratory tract surgery or instrumentation.

It may be also indicated as a prophylaxis of bacterial endocarditis in patients with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular lesions, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemic pulmonary shunts, mitral valve prolapse with valvular regurgitation of mitral valve prolapse without valvular regurgitation but associated with thickening and/or redundancy of the valve leaflets.

Contra-Indications: A history of a previous hypersensitivity reaction to any of the penicillins or cephalosporins is a contraindication.

Amoxicillin is also contraindicated in cases where infectious mononucleosis is either suspected or confirmed.

Manufacturers’ Warnings In Clinical States: Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients following oral dosing of penicillins. These reactions are more apt to occur in individuals with a history of sensitivity to multiple allergens. There have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with cephalosporins. Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If an allergic reaction occurs, administration of amoxicillin should be discontinued and appropriate therapy instituted.

Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, i.v. steroids and airway management, including intubation, should also be administered as indicated.

Precautions: Periodic assessment of renal, hepatic and hematopoietic functions should be made during prolonged therapy with amoxicillin.

Because amoxicillin is excreted mostly by the kidney, the dosage for patients with renal impairment should be reduced in proportion to the degree of loss of renal function.

Geriatrics: There are no known specific precautions for the use of amoxicillin in the elderly.

If superinfections with mycotic or bacterial pathogens occur (usually involving Aerobacter, Pseudomonas or Candida) treatment with amoxicillin should be discontinued and appropriate therapy instituted.

Pregnancy: The safety of amoxicillin in the treatment of infections during pregnancy has not been established. If the administration of amoxicillin to pregnant patients is considered to be necessary, its use requires that the potential benefits be weighed against the possible hazards to the fetus.

A morbilliform rash following the use of ampicillin in patients with infectious mononucleosis has been well documented and has also been reported to occur following the use of amoxicillin.

Adverse Reactions: As with other penicillins, it may be expected that untoward reactions will be related to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and cephalosporins and in those with a history of allergy, asthma, hay fever or urticaria.

The following adverse reactions have been reported as associated with the use of Novamoxin.

Gastrointestinal: nausea, vomiting and diarrhea.

Hypersensitivity Reactions: Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form.

Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy. Serious anaphylactic reactions require the immediate use of epinephrine, oxygen and i.v. steroids.

Liver: A moderate rise in AST has been noted, particularly in infants, but the significance of this finding is not known. Transient increases in serum alkaline phosphatase and lactic dehydrogenase levels have also been observed but they returned to normal on discontinuation of amoxicillin.

Hemic and Lymphatic: Anemia thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, neutropenia and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be a hypersensitivity phenomena.

Oral: glossitis, black “hairy” tongue and stomatitis.

CNS: As with other penicillins, acute and chronic toxicity is not a clinical problem. At extremely high doses, convulsions can occur. When penicillin reaches a high concentration in the cerebrospinal fluid, neurotoxic symptoms consisting of myoclonia, convulsive seizures and depressed consciousness may occur. Unless administration of the drug is stopped or its dosage reduced, the syndrome may progress to coma and death. Although penicillins do not normally cross the blood-brain barrier to any substantial extent, if massive doses are given (several grams per day) to elderly patients, patients with inflamed meninges or patients with impaired renal function, the above toxic reactions are likely to occur.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Treatment of overdosage would likely be needed only in patients with severely impaired renal function, since patients with normal kidneys excrete penicillins at a fast rate. Hemodialysis would, therefore, represent the main form of treatment.

Dosage And Administration: Infections of the upper respiratory tract (ear, nose and throat) due to susceptible strains of streptococci (beta-hemolytic and S. pneumoniae), nonpenicillinase-producing staphylococci and H. influenzae; infections of the urinary tract due to P. mirabilis and S. faecalis; infections of the skin and soft-tissues due to streptococci and staphylococci (nonpenicillinase producing): Adults: 250 mg every 8 hours.

Children
Children weighing 20 kg or more should be dosed according to the adult recommendations.

In severe infections or infections associated with organisms where sensitivity determinations require higher blood concentrations: 500 mg every 8 hours for adults and 40 mg/kg/day in divided doses every 8 hours for children less than 20 kg may be needed.

Infections of the lower respiratory tract, due to susceptible strains of the causative organism and acute otitis media: Adults: 500 mg every 8 hours.

Children
Children weighing 20 kg or more should be dosed according to the adult recommendations.

Urethritis due to nonpenicillinase producing N. gonorrhea acquired in area with active monitoring for resistance to penicillin and where the percentage of penicillin-resistant isolates is 45 kg: (3 g as a single oral dose); 1 g of oral probenecid should be administered concomitantly as well as appropriate therapy for presumptive or proven infection with C. trachomatis.

Children
For prevention of endocarditis: Adults: 3 g orally 1 hour before procedure; then 1.5 g 6 hours after the initial dose.

Children: 50 mg/kg (not to exceed adult dose) orally 1 hour before procedure; then 25 mg/kg 6 hours after the initial dose.

It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times and in stubborn infections therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhoea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days treatment for any infection caused by beta-hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

In order to obtain optimal absorption of drug from Novamoxin capsules they should be administered between meals with a glass of water (250 mL).

Directions for Dispensing Oral Suspension: Prepare these formulations at the time of dispensing. For ease in preparation, add water to the bottle in 2 portions and shake well after each addition. Add the total amount of water as directed on the labeling of the package being dispensed.

Availability And Storage: Capsules: 250 mg: Each hard gelatin capsule with opaque scarlet cap and yellow body imprinted NOVO 250 contains: amoxicillin BP (as the trihydrate) 250 mg (#2 capsules). Gluten-, sodium- and tartrazine-free. Bottles of 100, 500 and 1 000. Unit dose strips of 100.

500 mg: Each hard gelatin capsule with opaque scarlet cap and yellow body imprinted NOVO 500 contains: amoxicillin BP (as the trihydrate) 500 mg (#0 capsules). Gluten-, sodium- and tartrazine-free. Bottles of 100, 250, 500 and 1 000. Unit dose strips of 100.

Store between 15 and 30°C. Unit dose strips should be stored between 15 and 25°C and protected from high humidity.

Chewable Tablets: 125 mg: Each chewable, cherry-flavored, rose-colored, mottled, oval-shaped, single-scored, compressed tablet, engraved NOVO with scoreline on one side and 125 on the other side, contains: amoxicillin 125 mg as the trihydrate. Gluten- and tartrazine-free. Bottles of 100.

250 mg: Each chewable, cherry-flavored, rose-colored, mottled, oval-shaped, single-scored, compressed tablet, engraved NOVO with scoreline on one side and 250 on the other side, contains: amoxicillin 250 mg as the trihydrate. Bottles of 100 and 500. Gluten- and tartrazine-free.

Store between 15 and 30°C.

Suspension: 125 mg: Following reconstitution, each 5 mL of strawberry-flavored suspension contains: amoxicillin trihydrate equivalent to amoxicillin 125 mg. Energy: 48.5 kJ (11.6 kcal)/5 mL. Sodium:
250 mg: Following reconstitution, each 5 mL of orange/banana-flavored suspension contains: amoxicillin trihydrate equivalent to 250 mg amoxicillin. Energy: 46 kJ (11 kcal)/5 mL. Sodium:
Sugar-Reduced Suspension: 125 mg: Following reconstitution, each 5 mL of strawberry-flavored suspension contains: amoxicillin trihydrate equivalent to amoxicillin 125 mg. Gluten- and tartrazine-free. Bottles of 75, 100 and 150 mL.

250 mg: Following reconstitution, each 5 mL of orange/banana-flavored suspension contains: amoxicillin trihydrate equivalent to 250 mg amoxicillin. Gluten- and tartrazine-free. Bottles of 75, 100 and 150 mL.

Store granules for oral suspension at room temperature (between 15 and 30°C). Keep bottle tightly closed. The reconstituted formulation is stable for 14 days under refrigeration (between 2 and 8°C) or 7 days at room temperature (between 15 and 30°C).

NOVAMOXIN® Novopharm Amoxicillin Trihydrate Antibiotic

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