Drug "Sumamed ® forte" is applied at the infections caused by the microorganisms sensitive to azithromycin:
- ENT organs (bacterial pharyngitis / tonsillitis, sinusitis, average otitis);
- respiratory infection (bacterial bronchitis, community-acquired pneumonia);
- an infection of leather and soft tissues: the migrating erythema (initial stage of a disease of Lyme), an ugly face, impetigo, secondary pyodermatoses.
Structure
1 dose (5 ml) of suspension contains azithromycin (active ingredient) of 200 mg in the form of dihydrate azithromycin.
Excipients: sucrose, sodium phosphate, hydroxypropyl cellulose, xanthane gum, silicon dioxide colloidal waterless, fragrance banana, fragrance cherry, fragrance vanilla.
Contraindication
Hypersensitivity to azithromycin, erythromycin, to any makrolidny or ketolidny antibiotic and also to any other component of medicine.
Route of administration
"Sumamed ® forte", powder for oral suspension, is applied 1 time a day at least in 1 hour prior to or in 2 hours after a meal.
in case of the admission of reception of 1 dose of medicine should accept the passed dose as soon as possible, and the subsequent - with an interval of 24 hours.
Measuring off of a dose.
Packing has the syringe and a bilateral spoon for dosing or a unilateral measured spoon for dosing:
- unilateral spoon: has a tag of 2.5 ml and 3.75 ml, the spoon filled up to the top contains 5 ml;
- bilateral spoon: the big spoon filled up to the top contains 5 ml, it is less - 2.5 ml;
- syringe contains 5 ml.
Apply a spoon or the syringe by a doctor's advice.
Children.
In infections of ENT organs and airways, skin and soft tissues (except the chronic migrating erythema) the daily dose of azithromycin makes 10 mg/kg of body weight that corresponds to 0.25 ml/kg of body weight of ready suspension. Duration of treatment is 3 days.
toDepending on the body weight of the child recommends the following scheme of dosing of suspension "Sumamed ® forte":
| Body weight (kg) | Daily dose of suspension (ml) | Frequency rate of reception | azithromycin Content in a daily dose of suspension |
| 15-24 | 5 | 1 times/day | 200 mg |
| 25-34 | 7.5 | 300 mg | |
| 35-44 | 10 | 400 mg | |
| ≥45 | 12.5 | 500 mg |
Preparation and use of suspension.
needs to add the distilled or boiled and chilled water To a bottle which contains powder.
Cover of a bottle to press- down and to turn counterclockwise.
- From clean ware by means of the syringe for dosing to measure the corresponding amount of water (9.5 or 16.5 or 20.0 ml) and to add to a bottle with powder:
- Bottle with powder for oral suspension of 200 mg / 5 ml on 15 ml: to add 9.5 ml of water to contents of a bottle. Carefully to shake up bottle contents before receiving uniform suspension. The volume of the received suspension is about 20 ml*.
- Bottle with powder for oral suspension of 200 mg / 5 ml on 30 ml: to add 16.5 ml of water to contents of a bottle. Carefully to shake up bottle contents before receiving uniform suspension. The volume of the received suspension is about 35 ml*.
- Bottle with powder for oral suspension of 200 mg / 5 ml on 37.5 ml: to add 20 ml of water to contents of a bottle. Carefully to shake up bottle contents before receiving uniform suspension. The volume of the received suspension is about 42.5 ml*.
* After powder dissolution the bottle will contain additional 5 ml of suspension (for compensation of possible losses of suspension in the application).
| Amount of water which needs to be added to a bottle for receiving suspension (ml) | |
| 15 ml | 9.5 |
| 30 ml | 16.5 |
| 37.5 ml | 20 |
** Information on the volume of a bottle is placed by
on a box and the label of a bottle.
- to Ship the syringe in suspension and, extending the piston up, to measure necessary amount of suspension.
- If in the syringe vials of air are available, it is necessary to return medicine to a bottle and to repeat procedure 3. to Arrange
- child as for feeding. Tip of the syringe to put
- in a mouth to the child and to slowly squeeze out contents.
- to Give to the child the chance to gradually swallow all quantity.
- After administration of medicament to allow the child to drink a little tea or juice to wash away and swallow residues of suspension in an oral cavity. Used syringe to sort, wash
- with flowing water, to dry up and store in the dry and clean place together with medicine.
- After the child accepted the last dose of medicine, the syringe and a bottle it is necessary to utilize.
At migrating erythema duration of treatment is 5 days. In the 1st day it is necessary to accept 20 mg/kg of body weight of azithromycin that corresponds to 0.5 ml/kg of ready suspension. From 2 to 5 day to accept 10 mg/kg of body weight that corresponds to 0.25 ml/kg of ready suspension.
General course dose makes 60 mg/kg.
| Days treatment | 1 | 2 | 3 | 4 | 5 |
| Daily dose (ml/kg) | 0.5 | 0.25 | 0.25 | 0.25 | 0.25 |
Was shown that azithromycin is effective at treatment of streptococcal pharyngitis at children in the form of a single dose of 10 mg/kg or 20 mg/kg within 3 days. When comparing these two doses in clinical trials the similar clinical performance was found though the bacterial eradikation was more considerable at a daily dose of 20 mg/kg. However usually choice medicine for prevention of the pharyngitis caused by Streptococcus pyogenes and rheumatic polyarthritis which arises as a secondary disease is penicillin.
Adult.
In infections of ENT organs and airways, skin and soft tissues (except the chronic migrating erythema) the general dose of azithromycin makes 1500 mg: on 500 mg of 1 times a day. Duration of treatment is 3 days.
At migrating erythema general dose of azithromycin makes 3 g: in the 1st day it is necessary to accept 1 g, then on 500 mg of 1 times a day from the 2nd to the 5th day. Duration of treatment is 5 days.
Feature of application
Pregnant women
Are not present adequate data on use of azithromycin to pregnant women. In researches of reproductive toxicity at animals of a teratogenic adverse effect of azithromycin on a fruit it is noted, however medicine got through a placenta. Safety of use of azithromycin during pregnancy is not confirmed. Therefore azithromycin is appointed during pregnancy, only if the advantage exceeds risk.
Feeding by a breast. It was reported, that azithromycin gets into breast milk, but corresponding and properly controlled clinical trials which would give the chance to characterize pharmacokinetics of excretion of azithromycin in breast milk, was not carried out.
Fertility. Research of fertility was conducted on rats; the indicator of pregnancy decreased after administration of azithromycin. The relevance of these data on the person is unknown.
Children to Children with body weight less than 15 kg recommends to appointby
"Sumamed ® " (100 mg / 5 ml). "Sumamed ® forte" more than 15 kg appoint to children with body weight.
Drivers
Proof that azithromycin can worsen ability to steer motor transport or other mechanisms are absent, but it is necessary to consider a possibility of development of side reactions, such as delirium, hallucinations, dizziness, drowsiness.
Overdose
Experience of clinical use of azithromycin demonstrates to what side effects which develop at reception of higher than is recommended, medicine doses, are similar to those that are observed at application of usual therapeutic doses. They can include diarrhea, nausea, vomiting, a reverse hearing loss. In case of overdose if necessary intake of activated carbon and performing the general symptomatic and supporting treatment is recommended.
Side reactions
In the following table according to a class of systems and bodies and frequencies it is specified by p the side reactions defined in clinical trials and in the period of post-marketing observation observed at application of all dosage forms of azithromycin. The side reactions registered in the period of post-marketing observation are italicized. Groups on the frequency of manifestations were determined by the following scale: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100); seldom (≥ 1/10000 to <1/1000), it is very rare (<1/10000); it is unknown (it is impossible to determine by the available data). Within each group on frequency the undesirable phenomena are given in an order of reduction of their weight.
Side reactions perhaps or possibly connected with azithromycin, on the basis of the data obtained during clinical trials and during post-marketing observation.
| Class of systems and bodies | to Side reaction | to Frequency |
| Infection and an invasion | to Candidiasis, vaginal infections, pneumonia, a fungal infection, a bacterial infection, pharyngitis, a gastroenteritis, breath dysfunction, rhinitis, oral candidiasis | to infrequently |
| Pseudomembranous colitis | does not know to
| |
| from blood and lymphatic system | Leukopenia, a neutropenia, an eosinophilia | infrequently |
| Thrombocytopenia, hemolytic anemia | is unknown | |
| from the immune system | Quincke's disease, reaction of hypersensitivity | to infrequently |
| Anaphylactic reaction | does not know to
| |
| from a metabolism | Anorexia | infrequently |
| from mentality | Nervousness, insomnia | infrequently |
| Agitation | is rare | |
| Aggression, alarm, a delirium, hallucinations | does not know to
| |
| from nervous system | Headache | is frequent |
| Dizziness, drowsiness, a dysgeusia, paresthesias | infrequently | |
| Faint, spasms, a hypesthesia, psychomotor superactivity, an anosmia, an ageusia, a parosmiya, a myasthenia gravis | does not know to
| |
| from organs of sight | Disorder of vision | infrequently |
| from organs of hearing | Disorder from organs of hearing, vertigo | infrequently |
| Hearing disorder, including deafness and/or a ring in ears | does not know to
| |
| from heart | Palpitation | infrequently |
| Trembling/fibrillation of ventricles (torsade de pointes), arrhythmia, including ventricular tachycardia, | to does not know lengthening of a QT interval on the ECG | |
| from vessels | Inflows | infrequently |
| Arterial hypotension | is unknown | |
| from a respiratory system | Dispnoe, nasal bleeding | infrequently |
| from a digestive tract | Diarrhea | is very frequent
|
| Vomiting, an abdominal pain, nausea | it is frequent | |
| Constipation, a meteorism, dyspepsia, gastritis, a dysphagy, an abdominal distension, dryness in a mouth, an eructation, ulcers in an oral cavity, saliva hypersecretion | to infrequently | |
| Pancreatitis, discoloration of language | does not know to
| |
| from a gepatobiliarny system | Abnormal liver function, cholestatic jaundice | it is rare |
| Liver failure (which seldom led to a lethal outcome), fulminantny hepatitis, liver necrosis | is unknown | |
| from skin and hypodermic cellulose | Rash, an itch, urticaria, dermatitis, xeroderma, a hyperhidrosis infrequently | |
| Photosensitivity, sharp generalized exanthematous pustulyoz | is rare |
|
| Stephens-Johnson's Syndrome, a toxic epidermal necrolysis, a polymorphic erythema, reaction to medicine with an eosinophilia and system symptoms | is unknown | |
| from a musculoskeletal system | Osteoarthritis, myalgia, a dorsodynia, neck pain | infrequently |
| Arthralgia | is unknown | |
| from an urinary system | Dysuria, kidney pain | infrequently |
| Acute renal failure, interstitial nephrite | is unknown | |
| from a reproductive system and mammary glands | Uterine bleeding, testicular violations | infrequently |
| General violations and local reactions | Hypostasis, an adynamy, an indisposition, fatigue, a face edema, a stethalgia, a hyperthermia, pain, peripheral hypostasis | infrequently |
| Laboratory indicators | Lowered quantity of lymphocytes, the increased quantity of eosinophils, reduced level of bicarbonate of blood, increase in level of basophiles, increase in level of monocytes, increase in level of neutrophils | is frequent |
| Increased AsAT, AlAT level, bilirubin of blood, urea in blood, blood creatinine; changes of indicators of potassium in blood, increase in level of alkaline phosphatase, chloride, glucose, platelets; decrease in level of a hematocrit; increase in level of bicarbonate, a sodium level aberration | infrequently | |
| Defeat and poisoning | Complication after the procedure | infrequently |
Information on side effects which, perhaps, are connected with prevention and treatment Mycobacterium Avium Complex is based on data of clinical trials and observations during the post-marketing period. These undesirable reactions differ on type or on frequency from about what it was reported at application of high-speed dosage forms and dosage forms of long action.
Undesirable reactions which are perhaps connected with prevention and treatment of Mycobacterium Avium Complex.
| Class of systems and bodies | Side reaction | Frequency |
| from a metabolism | Anorexia | it is frequent |
| from nervous system | Dizziness, a headache, paresthesias, a dysgeusia | is frequent |
| Hypesthesia | infrequently | |
| from organs of sight | Disorder of vision | is frequent |
| from organs of hearing | Deafness | is frequent |
| Hearing disorder, a ring in ears | infrequently | |
| from heart | Palpitation | infrequently |
| from a digestive tract | Diarrhea, an abdominal pain, nausea, a meteorism, gastrointestinal discomfort, a frequent liquid chair | is very frequent |
| from digestive system | Hepatitis | infrequently |
| from skin and hypodermic cellulose | Rash, an itch is frequent |
|
| Stephens-Johnson's Syndrome, photosensitivity | infrequently | |
| from a musculoskeletal system | Arthralgia | is frequent |
| General violations and local reactions | Increased fatigue | is frequent |
| Asthenia, an indisposition | infrequently | |
Storage conditions
to Store at a temperature not above 25 °C, out of children's reach.
to Store ready suspension at a temperature not above 25 °C.
Expiration date - 2 years.
Expiration date of ready suspension - 10 days.
| Characteristics | |
| Active ingredients | Azithromycin |
| Amount of active ingredient | 40 mg/ml |
| Applicant | Teva |
| Code of automatic telephone exchange | J01FA10 Azithromycin |
| Interaction with food | To |
| Light sensitivity | Not sensitive |
| Market status | The branded generic |
| Origin | Chemical |
| Prescription status | According to the prescription |
| Primary packing | bottle |
| Producer | D.O.O. PLIVA HRVATSKA. |
| Quantity in packing | 37.5 ml |
| Release form | powder for internal use |
| Route of administration | Oral |
| Sign | Import |
| Storage temperature | from 5 °C to 25 °C |
| Trade name | Sumamed |
Sumamed forte time. for shouted. susp. 200mg/5ml fl. 37.5 ml
- Product Code: 179553
- In Stock
- Ready to ship
-
$38.96
Related Products
Last Viewed
advertising
This product is bought 24 people. Buy it now?