Ospamox powder for suspension 125 mg/5 ml. 60 ml. vial

Description

Ospamox composition
active substance: amoxicillin;
5 ml of suspension contain amoxicillin 125 mg  in the form of amoxicillin trihydrate;
Excipients: anhydrous citric acid, sodium benzoate (E 211), aspartame (E 951), talc, trisodium anhydrous citrate, guar gum, precipitated silicon dioxide, lemon flavor powder, peach-apricot flavor, powder flavor.

Dosage form
Powder for oral suspension.

Pharmacological properties
Is an antibiotic-penicillin, which has a wide range of activity. Kills pathogenic microbes, acts on the walls of their cells.

Indication
Ospamox is intended for the treatment of the following infections:

• acute bacterial sinusitis;
• acute otitis media;
• acute streptococcal tonsillitis and pharyngitis;
• exacerbation of chronic bronchitis;
• community-acquired pneumonia;
• acute cystitis;
• asymptomatic bacteriuria during pregnancy;
• acute pyelonephritis;
• typhoid and paratyphoid fever;
• dental abscesses with widespread cellulite;
• infections of prosthetic joints;
• eradication of Helicobacter pylori (as part of combination therapy);
• Lyme disease.

The drug is used for the treatment and prevention of endocarditis.

Contraindication
Hypersensitivity to amoxicillin, other penicillins or excipients. Presence of a history of severe hypersensitivity reactions (including anaphylaxis) to beta-lactam antibiotics (including cephalosporins, carbapenems or monobactams).

Use during pregnancy or breastfeeding
Amoxicillin crosses the placental barrier; its concentration in the blood plasma of the fetus is approximately 25-30% of the concentration in the blood plasma of the pregnant woman. Limited data on the use of amoxicillin during pregnancy indicate no adverse effects on the fetus / newborn. Animal studies have shown no teratogenic effects of amoxicillin. If amoxicillin is required during pregnancy, a careful assessment of the potential risk to the fetus and the expected benefit to the woman should be made.
Amoxicillin is excreted in small amounts in breast milk, so the risk of developing hypersensitivity in the child during breastfeeding cannot be ruled out. The use of the drug during this period is possible only when the expected benefit to the woman outweighs the potential risk to the child. Breastfeeding should be stopped if the newborn has gastrointestinal disorders (diarrhea), candidiasis or skin rashes.

Method of application and dosage
The drug Ospamox should be used in accordance with official recommendations for antibiotic therapy and data on local sensitivity to the antibiotic, if any. Sensitivity to amoxicillin / clavulanate varies from region to region and may change over time. If necessary, the sensitivity of the microorganism to the antibiotic should be determined.
Doses of the drug are prescribed by the doctor depending on the expected microorganisms and their sensitivity to antibacterial drugs, the severity of the disease and the location of the infection, age, body weight and renal function of the patient.
The duration of treatment is determined by the patient’s clinical response to treatment. Some infections (such as osteomyelitis) require longer treatment. Treatment should not last more than 14 days without revision.

• Adults and children weighing ≥ 40 kg: other forms of Ospamox should be used.
• Children weighing <40 kg
  Recommended daily doses: from 25 / 3.6 mg / kg body weight to 45 / 6.4 mg / kg body weight, divided into 2 doses.
  For children weighing <40 kg, the drug is prescribed in a maximum daily dose of 1000-2800 mg of amoxicillin when used as described below.

Approximate calculation of the suspension of Ospamox (ml) per day depending on body weight:

• 5 kg – 2.5 – 5 ml per day;
• 7 kg – 5 – 7.5 ml per day;
• 10 kg – 7.5 – 10 ml per day;
• 12 kg – 7.5 – 12.5 ml per day;
• 15 kg – 10 – 15 ml per day;
• 17 kg – 10 – 20 ml per day;
• 20 kg – 12.5 – 22.5 ml per day;
• 22 kg – 15 – 25 ml per day;
• 25 kg – 15 – 27.5 ml per day;
• 27 kg – 17.5 – 30 ml per day;
• 30 kg – 20 – 32.5 ml per day.

Overdose
Symptoms: digestive tract dysfunction – nausea, vomiting, diarrhea, which may result in water-electrolyte imbalance.
Cases of crystalluria have been reported, sometimes leading to renal failure.
Patients with impaired renal function or those receiving high doses of amoxicillin may experience seizures.
Treatment: induce vomiting or gastric lavage, then take activated charcoal and osmotic laxative. Water and electrolyte balance should be maintained. Amoxicillin can be removed from the bloodstream by hemodialysis. The specific antidote is unknown.

Side effects:

• Infections and infestations: Prolonged or repeated use of the drug may lead to the development of superinfections and excessive growth of insensitive microorganisms or yeast that cause candidiasis of the skin and mucous membranes.
• From the blood and lymphatic system: eosinophilia, hemolytic anemia; leukopenia, severe neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, myelosuppression, granulocytopenia, increased bleeding time and prothrombin index. These manifestations are reversible if treatment is stopped.
• From the immune system: severe allergic reactions, including angioneurotic edema (Quincke’s edema), anaphylaxis, serum sickness, allergic vasculitis, laryngeal edema, anaphylactic shock.
• From the digestive tract: diarrhea, nausea, vomiting, flatulence, stomach pain, soft stools, itching in the anus, loss of appetite, enanthema (especially in the mouth), dry mouth, taste disturbance; single – discoloration of the tooth surface (especially in children when taking the suspension). Proper hygienic procedures for the oral cavity can prevent discoloration of the teeth, as such plaque is mostly removed when brushing teeth; rare – antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis), intestinal candidiasis, black tongue. These side effects are generally not severe and go away either during treatment or immediately after treatment. Such phenomena can be prevented by using amoxicillin with food.
• From the nervous system: hyperkinesia, hyperactivity, dizziness, convulsions (in patients with epilepsy and meningitis, in case of renal impairment, with high doses of amoxicillin), aseptic meningitis.
• From the hepatobiliary system: hepatitis, cholestatic jaundice, moderate and short-term increase in liver enzymes (AST, ALT).
• From the skin and subcutaneous tissue: skin rash, urticaria, itching; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis, Lyell’s syndrome, drug reaction in the form of eosinophilia and systemic manifestations (DRESS syndrome).
  Sudden onset of urticaria indicates an allergic reaction to amoxicillin and requires immediate discontinuation of therapy.
• From the kidneys and urinary system: acute interstitial nephritis, crystalluria.
• Others: fever.

Expiration date
3 years.

Storage conditions
Store at a temperature not exceeding 25 ° C in the original package.
Keep out of reach of children.
The finished suspension should be used within 14 days, the suspension should be stored in a refrigerator (2-8 ° C).