AMOXICLAV Devatis Forte (Amoxycillin and Clavulanic Acid 50MG/1ML / 12.5MG/1ML) Oral Suspension

General Information

What is  Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml used for?

Amoxiclav Devatis Forte is an antibiotic suspension containing a combination of amoxicillin (a penicillin) and clavulanic acid (a beta-lactamase inhibitor). The "50/12.5" refers to the concentration of active ingredients per milliliter (mL). Each 1 mL of the reconstituted suspension contains 50 mg of amoxicillin and 12.5 mg of clavulanic acid. This is typically known as a 250 mg / 62.5 mg per 5 mL suspension.

Amoxiclav Devatis Forte is indicated for the short- term treatment of common bacterial infections in adults and children such as:

• Upper Respiratory Tract Infections (including ENT): e.g. tonsillitis, sinusitis, otitis media

 · Lower Respiratory Tract Infections: e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia

• Genito-urinary Tract Infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections
• Skin and Soft Tissue Infections such as cellulitis or animal bites
• Bone and Joint Infections: e.g. osteomyelitis

 · Other Infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis, post-surgical infection

How does Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml work?

Amoxiclav Devatis Forte (250mg/62.5mg per 5ml) is an antibiotic combining amoxicillin and clavulanic acid to treat bacterial infections. Amoxicillin kills bacteria by preventing them from forming essential cell walls, while clavulanic acid inhibits protective enzymes produced by bacteria, preventing them from destroying the amoxicillin. 

Key Mechanisms of Action:

• Active Ingredients: It is a penicillin-type antibiotic, combining Amoxicillin (250 mg/5mL) with Potassium Clavulanate (62.5 mg/5mL).
• Dual Action: Amoxicillin acts as the primary antibiotic killing bacteria, while clavulanic acid acts as a "shield," allowing amoxicillin to work against resistant bacteria that would otherwise break it down.
• Targeted Infections: It is used to treat short-term bacterial infections of the ears, sinuses, respiratory tract, skin, and urinary tract.
• Effectiveness: It is highly effective, but it will not work against viral infections like the cold or flu.
• Administration: It is typically taken with food to reduce potential gastrointestinal side effects and enhance absorption. 

For best results, it should be taken for the full duration prescribed, even if symptoms subside after 2–3 days. 

What does Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml contain?

• Active Ingredients: Each 1 mL of the reconstituted suspension contains 50 mg of amoxicillin and 12.5 mg of clavulanic acid.
• Common Formulation: This is typically known as a 250 mg / 62.5 mg per 5 mL suspension.
• Ratio: It follows a 4:1 ratio of amoxicillin to clavulanic acid. 

What are the side effects of Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml?

Common side effects of Amoxiclav Devatis Forte include diarrhoea, nausea, vomiting, abdominal pain, and skin rashes. It may also cause oral or vaginal thrush, dizziness, headache, and rarely, liver issues or serious allergic reactions like severe skin rash or swelling. 

Common Side Effects

• Gastrointestinal: Diarrhoea (very common), nausea, vomiting, abdominal discomfort/pain, indigestion.
• Skin: Rash, hives.
• Other: Oral thrush (white, furry tongue/mouth patches), vaginal thrush (itching/discharge). 

Serious Side Effects (Seek Medical Attention Immediately)

• Severe Allergic Reactions: Swelling of the face, lips, mouth, or tongue, difficulty breathing or swallowing, rash, fever, or joint pain.
• Severe Diarrhoea: Watery or bloody diarrhoea, which may be accompanied by stomach cramps and fever, indicating potential antibiotic-associated colitis.
• Liver Issues: Yellowing of the skin or eyes (jaundice), dark urine, pale stools, severe, unexplained nausea or vomiting.
• Skin Reactions: Severe skin rashes, blistering, or peeling.
• Other: Seizures, bleeding, or bruising. 

Managing Side Effects

• Taking the medicine with a meal can reduce stomach issues.
• If your child vomits within 30 minutes of taking the dose, it can be repeated, but do not double dose if later.

If side effects are persistent or severe, contact a Doctor or your Health Professional. 

When should Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml not be used?

Amoxiclav Devatis Forte must not be used if you have a history of allergic reactions to penicillins, cephalosporins, or similar antibiotics, or if you have previously experienced liver issues/jaundice linked to this medication. It is also contraindicated for patients with severe renal impairment. 

Key Situations to Avoid Use:

• Allergic History: If you have experienced severe allergic reactions (e.g., anaphylaxis, rashes, difficulty breathing) to any penicillin or similar antibiotic.
• Liver Disease: If you have had liver problems, specifically cholestatic jaundice, caused by taking Amoxiclav previously.
• Mononucleosis (Mono): Should not be used if suspected, as it may increase the risk of a rash.
• Expired or Damaged Medication: Do not use if the product is past its expiry date or if the bottle appears damaged.
• Long-Term Storage: The reconstituted suspension should not be used if it has been stored for more than 7 days. 

Precautions:

• Caution with Kidney/Liver Issues: Consult a doctor if you have kidney or liver disease, as a dosage adjustment may be necessary.
• Phenylketonuria (PKU): This medication contains phenylalanine, which may be harmful to individuals with PKU.
• Pregnancy/Breastfeeding: Consult a healthcare provider, though generally considered safe, it is not a strict contra-indication. 

If you develop a skin rash, yellowing of the skin/eyes (jaundice), or severe diarrhoea, stop using this medication immediately and seek medical attention. 

What medications interact with Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml?

Amoxiclav Devatis Forte interacts with several medications, most notably increasing the risk of bleeding with blood thinners like Warfarin. It also reduces the effectiveness of oral contraceptives and increases the risk of rashes with allopurinol. Other significant interactions include methotrexate, probenecid, and mycophenolate mofetil. 

Key Medication Interactions:

• Anticoagulants (Blood Thinners): Increased risk of bleeding with warfarin, acenocoumarol, or other blood thinners.
• Gout Medication: Probenecid should not be used concurrently as it increases and prolongs blood levels of amoxicillin. Allopurinol increases the likelihood of allergic skin reactions.
• Oral Contraceptives: Reduced efficacy of birth control pills, requiring additional, non-hormonal, contraceptive methods.
• Methotrexate: Increased toxicity of methotrexate, used for cancer and psoriasis.
• Mycophenolate Mofetil: May reduce the effectiveness of this immunosuppressant.
• Lab Tests: Can cause false-positive results in urine glucose tests (e.g., Clinitest). 

Other Precautions:

• Alcohol: Generally advised to avoid or limit alcohol, as it can worsen potential stomach upset.
• Probiotics: May decrease the effectiveness of probiotics if taken at the same time. 

Ensure all Healthcare providers, including dentists and pharmacists, are aware you are taking this medication. Inform your doctor if you are taking any other prescription, over-the-counter, or herbal products. 

How should Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml be used and for how long?

1. Reconstitution: Tap the bottle to loosen the powder, then add the specific amount of water indicated on the label (usually in two stages) and shake vigorously.
2. Storage: Once mixed, the suspension must be refrigerated (2°C to 8°C).
3. Shelf Life: Discard any unused portion after 7 to 10 days, depending on the specific manufacturer's instructions. 

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days.

 · If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

• Amoxiclav Devatis Forte is not usually used for longer than 14 days without another check-up by your Health Professional.

Missed dose of Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml

Amoxiclav Devatis Forte should be taken regularly at the same time each day.

 If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you have missed.

If you are not sure whether to skip the dose, talk to your Doctor or Pharmacist

How should Amoxiclav Devatis Forte Oral Suspension 250/62.5mg/5ml  be stored?

Dry powder: Store below 25°C in the original package in order to protect from light and moisture.

Liquid suspension: Reconstituted suspension should be stored at 2°C–8°C (Refrigerate, do not freeze).