Amoxicillin (Panklav 2X) is an antibiotic in a group of drugs called penicillins. Amoxicillin (Panklav 2X) fights bacteria in the body.
Clavulanate potassium is a form of Clavulanic Acid (Panklav 2X), which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.
The combination of Amoxicillin (Panklav 2X) and clavulanate potassium is used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.
Amoxicillin (Panklav 2X) and clavulanate potassium may also be used for purposes not listed in this medication guide.
Panklav 2X indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Panklav 2X-600 is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including β-lactamase–producing strains), or M. catarrhalis (including β-lactamase–producing strains) characterized by the following risk factors:
antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:
age ≤ 2 years
daycare attendance
NOTE: Acute otitis media due to S. pneumoniae alone can be treated with Amoxicillin (Panklav 2X). Panklav 2X-600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL.
Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the β-lactamase–producing organisms listed above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Panklav 2X-600 and other antibacterial drugs, Panklav 2X-600 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Panklav 2X description
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Each film-coated tablet contains Amoxicillin (Panklav 2X) trihydrate equivalent to Amoxicillin (Panklav 2X) 500 mg, and potassium clavulanate equivalent to Clavulanic Acid (Panklav 2X) 125 mg, respectively.
Each vial contains Amoxicillin (Panklav 2X) sodium equivalent to Amoxicillin (Panklav 2X) 1000 mg and clavulanate potassium equivalent to Clavulanic Acid (Panklav 2X) 200 mg, respectively.
Panklav 2X tablets also contains the following excipients: Microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, povidone (K30), eudragit E 100, isopropyl alcohol, magnesium stearate, white opadryl 03B58965, PEG400, methylene chloride.
Panklav 2X is an antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin (Panklav 2X) and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of Clavulanic Acid (Panklav 2X)). Amoxicillin (Panklav 2X) is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Its molecular formula is C16H19N305S3H20 and the molecular weight is 419.46. Chemically, Amoxicillin (Panklav 2X) is (2S, 5R, 6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl) acetamido]-3, 3-dimethyl-7-oxo-4-1-azabicyclo[3.2.1] heptane-2-carboxylic acid trihydrate.
Amoxicillin (Panklav 2X): Clavulanic Acid (Panklav 2X) is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic Acid (Panklav 2X) is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KN05 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R, 5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate.
Panklav 2X dosage
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Panklav 2X-600, 600 mg/5 mL, does not contain the same amount of Clavulanic Acid (Panklav 2X) (as the potassium salt) as any of the other suspensions of AUGMENTIN. Panklav 2X-600 contains 42.9 mg of Clavulanic Acid (Panklav 2X) per 5 mL, whereas the 200 mg/5 mL suspension of AUGMENTIN contains 28.5 mg of Clavulanic Acid (Panklav 2X) per 5 mL and the 400 mg/5 mL suspension contains 57 mg of Clavulanic Acid (Panklav 2X) per 5 mL. Therefore, the 200 mg/5 mL and 400 mg/5 mL suspensions of AUGMENTIN should not be substituted for Panklav 2X-600, as they are not interchangeable.
Dosage
Pediatric patients 3 months and older: Based on the Amoxicillin (Panklav 2X) component (600 mg/5 mL), the recommended dose of Panklav 2X-600 is 90 mg/kg/day divided every 12 hours, administered for 10 days.
Body Weight (kg)
Volume of Panklav 2X-600 providing 90 mg/kg/day
8
3.0 mL twice daily
12
4.5 mL twice daily
16
6.0 mL twice daily
20
7.5 mL twice daily
24
9.0 mL twice daily
28
10.5 mL twice daily
32
12.0 mL twice daily
36
13.5 mL twice daily
Pediatric patients weighing 40 kg and more: Experience with Panklav 2X-600 (600 mg/5 mL formulation) in this group is not available.
Adults: Experience with Panklav 2X-600 (600 mg/5 mL formulation) in adults is not available and adults who have difficulty swallowing should not be given Panklav 2X-600 (600 mg/5 mL) in place of the 500-mg or 875-mg tablet of AUGMENTIN.
Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.
Directions for Mixing
Oral Suspension
Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.
Panklav 2X-600 (600 mg/5 mL Suspension)
Bottle Size
Amount of Water Required for Reconstitution
75 mL
70 mL
125 mL
110 mL
200 mL
180 mL
Each teaspoonful (5 mL) will contain 600 mg Amoxicillin (Panklav 2X) as the trihydrate and 42.9 mg of Clavulanic Acid (Panklav 2X) as the potassium salt.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
Information for the Pharmacist: For patients who wish to alter the taste of Panklav 2X-600, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of Panklav 2X-600. The resulting suspension is stable for 10 days under refrigeration. Other than the 5 flavors listed above, GlaxoSmithKline has not evaluated the stability of Panklav 2X-600 when mixed with other flavors distributed by FLAVORx.
Administration: To minimize the potential for gastrointestinal intolerance, Panklav 2X-600 should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Panklav 2X-600 is administered at the start of a meal.
How supplied
Panklav 2X-600, 600 mg/5 mL, for
Oral Suspension:
Each 5 mL of reconstituted strawberry cream-flavored suspension contains 600 mg Amoxicillin (Panklav 2X) and 42.9 mg Clavulanic Acid (Panklav 2X) as the potassium salt.
Administration of probenecid prior to dosing results in marked increase in the mean serum concentrations of Amoxicillin (Panklav 2X). Probenecid decreases the renal tubular secretion of Amoxicillin (Panklav 2X), but does not affect Clavulanic Acid (Panklav 2X) excretion. Concurrent use with Panklav 2X may result in increased and prolonged blood levels of Amoxicillin (Panklav 2X) but not of Clavulanic Acid (Panklav 2X).
When Amoxicillin (Panklav 2X) and warfarin are taken concomitantly, the INR can be altered.
Interaction of Panklav 2X with coumarin or indandione-derivative anticoagulants, heparin, NSAIDs especially aspirin, other platelet aggregation inhibitors or thrombolytic agents may be clinically significant.
Panklav 2X may decrease the efficacy of oestrogen-containing oral contraceptives. Patients should be warned accordingly. The simultaneous use of Amoxicillin (Panklav 2X) and an oral contraceptive might be expected to cause breakthrough bleeding or pregnancy on rare occasions because of reduced absorption owing to diarrhea, on the basis of experience with ampicillin.
The concurrent administration of allopurinol and ampicillin substantially increases the incidence of rashes in patients receiving both agents as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. There are no data on Amoxicillin (Panklav 2X)/clavulanate combination and allopurinol administered concurrently.
No information is available about the concurrent use of Panklav 2X and alcohol. However, the ingestion of alcohol whilst being treated with some other β-lactam antibiotics has precipitated a disulfiram (Antabuse)-like reaction in some patients. Therefore, the ingestion of alcohol should be avoided during and for several days after treatment with Panklav 2X.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugate oestriol, oestrio-glucuronide, conjugated oestrone and oestradiol has been noted. This effect may also occur with Amoxicillin (Panklav 2X) and therefore, Panklav 2X.
The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy.
The most frequently reported adverse effects were diarrhoea, nausea, vomiting, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes. The incidence and severity of adverse effects, particularly nausea and diarrhoea, increased with the higher recommended dose and can be minimised by administering the agent at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these GI symptoms occur and a higher concentration of Amoxicillin (Panklav 2X) is required, consideration should be given to administering the additional Amoxicillin (Panklav 2X) separately.
Hepatitis and cholestatic jaundice have been reported with the combination of Amoxicillin (Panklav 2X) and Clavulanic Acid (Panklav 2X); the Clavulanic Acid (Panklav 2X) component has been implicated. The events associated with Panklav 2X may be severe and occur predominantly in adult or elderly patients. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased. The hepatic events are usually reversible. However, in extremely rare circumstances, death has been reported. These have almost always been cases associated with serious underlying disease or concomitant medication.
A moderate rise in aspartate transaminase and/or alanine transaminase has been noted in patients treated with Panklav 2X, the significance of these findings is unknown.
The following adverse reactions have been reported for ampicillin class antibiotics and may occur with Panklav 2X.
Gastrointestinal: Gastritis, stomatitis, glossitis, black hairy tongue, enterocolitis and pseudomembranous colitis. If GI reactions are evident, they may be reduced by taking Panklav 2X at the start of a meal.
Amoxicillin (Panklav 2X) causes hypersensitivity reactions similar to those induced by penicillin G and ampicillin, including rashes and fever. The incidence of these reaction is probably no higher than with other penicillins. Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or uticaria. Hypersensitivity reactions include skin rashes, urticaria, erythema multiforme, rare cases of Stevens-Johnson syndrome and less frequently exfoliative dermatitis and toxic epidermal necrolysis have been reported. Whenever such reactions occur, Panklav 2X should be discontinued. Serious and occasional fatal hypersensitivity (anaphylactic) reactions and angioneurotic oedema can occur with oral penicillin.
Haematopoietic and Lymphatic: Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in patients treated with Panklav 2X. Prolongation of bleeding time and prothrombin time have also been reported less frequently.
Amoxicillin (Panklav 2X) alone or in combination with Clavulanic Acid (Panklav 2X) has been associated with acute hepatic dysfunction. The incidence rate (95% confidence intervals) were 1.7 (1.1-2.7) (Amoxicillin (Panklav 2X)-Clavulanic Acid (Panklav 2X)) and 0.3 (0.2-0.5)/10,000 prescriptions (Amoxicillin (Panklav 2X) alone). Risks were increased in patients receiving >1 course and in older recipients.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes and/or dizziness have also been reported. Depression, seizures or hallucinations.
Panklav 2X contraindications
Hypersensitivity to the Amoxicillin (Panklav 2X)/clavulanate potassium to any of the penicillins or to any of the excipients of Panklav 2X.
History of a severe immediate hypersensitivity reaction (eg, anaphylaxis) to another β-lactam agent (eg, a cephalosporin, carbapenem or monobactam).
History of cholestatic jaundice/hepatic dysfunction due to Panklav 2X.
DailyMed. "AMOXICILLIN; CLAVULANATE POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Panklav 2X are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Panklav 2X. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported useful
No survey data has been collected yet
2 consumers reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Panklav 2X drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users
%
Not expensive
2
100.0%
3 consumers reported time for results
To what extent do I have to use Panklav 2X before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes 3 days and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Panklav 2X. To get the time effectiveness of using Panklav 2X drug by other patients, please click here.
Users
%
3 days
1
33.3%
1 day
1
33.3%
1 week
1
33.3%
14 consumers reported age
Users
%
16-29
7
50.0%
30-45
2
14.3%
46-60
2
14.3%
6-15
1
7.1%
1-5
1
7.1%
> 60
1
7.1%
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