V-MOX-CA

Available composition

V-MOX-CA-375 TABLETS Each film coated tablets contains: Amoxicillin trihydrate eq to amoxicillin 250 mg & potassium clavulanate eq to clavulanic acid 125 mg.

V-MOX-CA-625 TABLETS Each film coated tablets contains: Amoxicillin trihydrate eq to amoxicillin 500 mg & potassium clavulanate eq to clavulanic acid 125 mg.

V-MOX-CA-1000 TABLETS Each film coated tablets contains: Amoxicillin trihydrate eq to amoxicillin 875 mg & potassium clavulanate eq to clavulanic acid 125 mg.

V-MOX-CA ORAL SUSPENSIONEach ml of reconstituted suspension contains: Amoxicillin trihydrate eq. to amoxicillin 200mg & potassium clavulanate P eq to clavulanic acid 28.5 mg.

 PHARMACOLOGICAL CLASSIFICATION  Broad spectrum antibiotic, penicillin 

MECHANISM OF ACTION: Clavulanic acid binds and inhibits beta-lactamases that inactivate amoxicillin resulting in amoxicillin having an expanded spectrum of activity. Amoxicillin inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested. 

PHARMACOKINETICS :V-MOX-CA is administered orally as tablets and oral suspension. The pharmacokinetics are similar between all dosage forms. Both amoxicillin and clavulanic acid are stable against gastric acid and are well absorbed from the GI tract. Approximately 74—92% of a dose of amoxicillin is absorbed. Peak serum levels of both amoxicillin and clavulanic acid occur within 1—2.5 hours following an oral dose. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin; however, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. High-fat meals decrease the absorption of clavulanic acid. In general, all dosage forms are recommended to be taken at the start of a meal. Protein-binding is approximately 17—20% for amoxicillin and 22—30% for clavulanic acid. Amoxicillin is distributed into liver, gallbladder, prostate, middle ear effusions, bronchial secretions, maxillary sinus secretions, and synovial fluid. Both amoxicillin and clavulanic acid are distributed into lungs, urine, and pleural and peritoneal fluids. Minimal levels are attained within the CSF when meninges are not inflamed; these levels are increased with inflammation. The drug does cross the placenta.

Approximately 10% of an amoxicillin dose is metabolized to inactive derivatives. Clavulanic acid appears to be extensively metabolized, although the exact mechanism is not fully established. Amoxicillin and its metabolites are excreted into the urine primarily via tubular secretion and glomerular filtration. Clavulanic acid is also cleared into urine via glomerular filtration. A small percentage of the drug is excreted in breast milk. In patients with normal renal function, the elimination half-lives of amoxicillin and clavulanic acid are 1—1.5 hours. The elimination half-lives increase as renal function declines—up to 7.5 hours for amoxicillin and 4.5 hours for clavulanic acid in patients with end-stage renal disease. Dosages need to be adjusted accordingly.

 INDICATIONS: V-MOX-CA is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:Lower Respiratory Tract Infections – caused by β-lactamase–producing strains of H. influenzae and M. catarrhalis.Otitis Media – caused by β-lactamase–producing strains of H. influenzae and M. catarrhalis.Sinusitis – caused by β-lactamase–producing strains of H. influenzae and M. catarrhalis.Skin and Skin Structure Infections – caused by β-lactamase–producing strains of S.aureus, E. coli, and Klebsiella spp.Urinary Tract Infections – caused by β-lactamase–producing strains of E. coli, Klebsiella spp., and Enterobacter spp.  

PATIENTS INFORMATION: BEFORE YOU TAKE V-MOX-CA: Before taking V-MOX-CA, tell your doctor:If you have ever had an allergic reaction to penicillin or to a cephalosporin, do not take V-MOX-CA without first talking to your doctor.Liver disease, kidney disease or mononucleosis. You may not be able to take V-MOX-CA, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.Amoxicillin and clavulanate potassium is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not, however, take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.V-MOX-CA passes into breast milk. Rarely, V-MOX-CA may cause a yeast infection, diarrhea, or allergic reaction in a nursing infant, although no serious harm is expected. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. HOW TO TAKE V-MOX-CATake V-MOX-CA exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.Take each dose with a full glass of water, V-MOX-CA should be taken with a meal or snack to reduce stomach upset.Shake the liquid form of V-MOX-CA well before measuring a dose. To ensure that you get a correct dose, measure the suspension with a dose-measuring spoonV-MOX-CA should be taken at evenly spaced intervals as prescribed. It is important to take V-MOX-CA regularly to get the most benefit.Take all of the V-MOX-CA that has been prescribed for you even if you begin to feel better. Symptoms may start to improve before the infection is completely treatedIF YOU MISS A DOSETake the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department.Symptoms of an amoxicillin and clavulanate potassium overdose include nausea, vomiting, stomach pain, rash, drowsiness, hyperactivity, and kidney problems.

TAKING OTHER MEDICINES

Before taking V-MOX-CA, tell your doctor if you are taking any of the following drugs:     Allopurinol, probenecid or another antibiotic (for the same or for a different infection). You may not be able to take V-MOX-CA, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.V-MOX-CA may decrease the effectiveness of birth control pills. Use a second method of birth control while taking V-MOX-CA to ensure protection from unintended pregnancy.Drugs other than those listed here may also interact with amoxicillin and clavulanate potassium. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.SIDE EFFECTSIf you experience any of the following serious side effects, stop taking V-MOX-CA and seek emergency medical attention or contact your doctor immediately:An allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting); or Diarrhea that is severe or lasts longer than 3 days. Other, less serious side effects may be more likely to occur. Continue to take V-MOX-CA and talk to your doctor if you experienceMild diarrhea, nausea or vomiting, rash, white patches in the mouth (thrush/yeast infection); or vaginal yeast infection or diaper rash. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

STORING: Store tablets at room temperature in a tightly closed container. Protect from moisture. The oral suspension may be stored either in the refrigerator or at room temperature. Replace the cap securely after each use. Discard any unused suspension after 10 days.

 V-TRAM-50

Available composition

V-TRAM-50

Each hard gelatin capsule contains: Tramadol hydrochloride 50 mg

V-TRAM-50

Available composition

V-TRAM-50

Each hard gelatin capsule contains: Tramadol hydrochloride 50 mg

PHARMACOLOGICAL CLASSIFICATION:

Analgesic

MECHANISM OF ACTION

Tramadol and its O-desmethyl metabolite (M1) are selective, weak OP3-receptor agonists. Opiate receptors are coupled with G-protein receptors and function as both positive and negative regulators of synaptic transmission via G-proteins that activate effector proteins. As the effector system is adenylate cyclase and cAMP located at the inner surface of the plasma membrane, opioids decrease intracellular cAMP by inhibiting adenylate cyclase. Subsequently, the release of nociceptive neurotransmitters such as substance P, GABA, dopamine, acetylcholine and noradrenaline is inhibited. The analgesic properties of Tramadol can be attributed to norepinephrine and serotonin reuptake blockade in the CNS, which inhibits pain transmission in the spinal cord.

PHARMACOKINETICS

Tramadol is readily absorbed following oral administration but is subjected to first pass metabolism. Tramadol is metabolized by N-and o-demethylation and glucronidation or sulfation in the liver. The metabolite o-desmethylationis pharmacologically active. Tramadol is excreted mainly in the urine predominantly as metabolites. Tramadol is widely distributed, crosses in placenta, and appear in small amount in breast milk. The elimination half life following oral administration is about 6 hours.

INDICATIONS:

Tramadol hydrochloride is an opioid analgesic. It also has noradrenergic and serotonergic properties that may contribute to its analgesic activity. Tramadol is used for moderate to severe pain.

Paient information:

Important

• The name of your medicine is V-TRAM-50. Before taking V-TRAM-50, please read this leaflet carefully. Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same

2. Do NOT take V-TRAM-50 when

• known hypersensitivity to tramadol or any excipients
• acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs
• patients who are taking MAO inhibitors or who have taken them within the last 14 days
• Known hypersensitivity to opioids.
• Patients with unrolled epilepsy or epilepsy not adequately controlled by treatment.
• If you are pregnant or if you are breast-feeding.
• If you have severe kidney disease.

Use in children

V-TRAM-50 is not recommended for children under 12 years.

Taking V-TRAM-50 with food and drink

You should avoid alcohol during treatment with V-TRAM-50

Driving and using machines

Do not drive or operate any tools or machines may make you drowsy or dizzy Taking other medicinesPlease inform your doctor or pharmacist

Taking other medicines

Please inform your doctor or pharmacist. Some medicines may interfere with V-TRAM-50. These include:Carbamazepine, coumarin derivatives, serotonin reuptake inhibitors, tricyclic anti-depressants, quinidine, phenothiazines or anti-psychotics, some antibiotics. How to take V-TRAM-50You should usually swallow one capsule twice a day every morning and evening. Swallow the capsule whole, not divided or chewed, with sufficient liquid, before, with, or after food.The recommended dosage of V-TRAM-50 is either:Two V-TRAM- 50 mg capsule(s) twice a day (morning and evening). Do not take more than eight of the 50 mg capsules per day.

If you forget to take V-TRAM-50

f you forget to take a dose, it is important to take another as soon as possible. Then go on as before.

What to do if an overdose is taken

In case of over dose do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department.

SIDE EFFECTS

Like all medicines, V-TRAM-50 can have side effects.The most common side-effects of V-TRAM-50 are:Dizziness, sedation, fatigue, headache,constipation,nausea, vomiting,sweating dry mouth.  The following side-effects are less common: Indigestion, changes in appetite,skin reactions,low blood pressure, collapse,muscle weakness,tremor, seizures,respiratory depression,improvement of mood, sleep disturbance,blurred vision,difficulty in passing urine Serotonin Syndrome: signs of this vary and are not specific; they may include fever, sweating, confusion, agitation, diarrhoea, muscle twitching, difficulty with walking and balance. Serotonin Syndrome may result from interaction of tramadol with other medicines which increase serotonin effects, for example, the SSRI antidepressants. skin rash (red spots or patches), itching hives, skin lumps,swelling or puffiness of the eyelids, face or lips,chest tightness, wheezing or pain in the chest,heart palpitations, faintness or collapse,hallucinations,convulsions.  

STORING V-TRAM-50

Keep V-TRAM-50 capsules where children cannot reach or see them. Keep in a cool, dry place. Do not store above 30°C.Do not use your capsules after the expiry date printed on the pack.