AMOKLAVIN BID Tablet

For short-term treatment of bacterial infections caused by bacteria susceptible to AMOKLAVIN in following conditions:

- Upper respiratory tract infections such as recurrent tonsillitis, sinusitis, otitis media

- Lower respiratory tract infections such as acute exacerbations of chronic bronchitis, broncho-pneumonia

- Genital organs and urinary tract infections such as inflammation of urinary tract, urethra (bladder) inflammation, bacterial inflammation of kidneys

- Skin and soft tissue infections such as boil, abscess (pockets of pus), cellulitis and wound infections

- Dental and gingival infections such as tooth abscess

- Abortion due to bacteria or toxins present in blood and tissues, puerperal fever, presence of bacteria and toxins in intra-abdominal blood and tissues.

Dosage

For adults and children aged over 12:

Mild to moderate infections: 625mg tablet twice daily.

Severe infections: 1g tablet twice daily.

Tooth infections;

Adults and children aged over 12: 625mg tablet twice daily for 5 days.

Duration of therapy should not exceed beyond 14 days without review.

Route and method of administration

Tablets should be swallowed as a whole without chewing. If required, tablets can be divided into two and swallowed without chewing.

They should be taken at the start of a meal to minimize gastrointestinal system disorders.

See the package insert about the details below:

- Use in children

- Use in elderly

- Renal and hepatic impairment

- If you are hypersensitive (allergic) to beta-lactam antibiotics (such as penicillin and cephalosporin).

- If you have ever had jaundice/hepatic impairment due to this medicine or penicillin treatment.

If you experience any of the following side effects, stop taking this medicine and inform your doctor straight away:

Very rare side effects:

- Swelling of face, lips, mouth, tongue or throat causing difficulty in swallowing or breathing (angioneurotic edema)

- Hyper-allergic condition (anaphylaxis) characterized by symptoms such as rash, itching or hives on the skin, swelling of face, lips, tongue or other parts of body, shortness of breath, wheezing or difficulty in breathing

- Allergic condition (serum sickness-like syndrome) characterized by symptoms such as rash, fever, joint pain and especially swelling of glands in armpit 7-12 days after the intake of medicine

- Inflammation of blood vessels (hypersensitivity vasculitis) which may be visible as red raised spots on the skin, rash and formation of bruises on skin

- A rare skin disease characterized by severe blisters in lips, eyes, mouth, nose and genital area and bleeding (Stevens Johnson Syndrome)

- Severe skin reaction which start as painful redness on the skin in the first place, continuing in layers. This disease is accompanied by fever, chill, muscle pains and general feeling of disorder. (Toxic Epidermal Necrolysis)

- Widespread red skin rash with small pus-containing blisters (Bullous exfoliative dermatitis)

- Red, scaly rash with bumps under the skin and blisters (Acute generalized exanthemous)

Rare side effects:

- Allergic condition characterized by symptoms such as itchy, red-purple colored spots especially on sole or pain, urticaria-like swellings on skin, hypersensitivity in mouth, eye and genital area, fever and fatigue (erythema multiforme)

There are all very serious side effects.

If you experience any of the following side effects, inform your doctor straight away:

If you experience any of the following side effects, stop taking this medicine and inform your doctor straight away:

Very rare side effects:

- Disease characterized by symptoms such as fever, severe chills, sore throat or common occurrence of infections like mouth ulcer (reversible agranulocytosis)

- Anemia characterized by symptoms such as weakness, headaches, shortness of breath during exercise, dizziness, paleness and yellowing of skin and eyes (hemolytic anemia)

- Generally bloody, mucous diarrhea

- Black tongue color

- Renal disease (interstitial nephritis)

- Crystals in urine (crystalluria)

- Liver disease characterized by nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of skin and eyes and coloured urine (hepatitis)

- Yellowing of skin and/or eyes (cholestatic hepatitis)

These are serious side effects. Serious side effects occur very rarely.

If you notice any of the following, tell your doctor:

Very rare side effects;

- Change in teeth color

As it is generally removed through brushing, change in teeth color can be prevented with good oral hygiene.

- Hyperactivity

- Convulsion, seizure or clonus

Uncommon side effects:

- Dizziness

- Headache

- Indigestion

- Skin rash

- Itching

- Hives

Common side effects

- Type of fungal infection affecting mucosa and skin (mucocutaneous candidiasis)

- Diarrhea

- Nausea

- Vomiting

(See the package insert about the details below.)

- Allopurinol

- Probenecid

- Medicines to help stop blood clots (such as warfarin)

- Methotrexate

Pregnancy

Consult your doctor or pharmacist before taking this medicine.

Breastfeeding

Consult your doctor or pharmacist before taking this medicine.

Breast-feeding might have to be discontinued.

(See the package insert about the details.)

Take special care with this medicine

- If you have history of hypersensitivity to penicillin, cephalosporin and other allergens, you should definitely tell your doctor.

- If you suspect infectious mononucleosis (an infection disease), (occurrence of a morbilliform rash following the use of amoxicillin can be associated with infectious mononucleosis).

- Use this medicine during the period recommended by your doctor. Its long-term use results in overgrowth of organisms not susceptible to this medicine (e.g. fungi).

- Prolongation of bleeding and prothrombin time has been reported in some patients receiving this medicine. Appropriate monitoring should be undertaken if you will use it concomitantly with anticoagulants.

- If you have hepatic impairment.

- Cholestatic Jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent until 6 weeks after treatment has ceased.

- If you have renal impairment, the dose you will take should be adjusted according to the degree of impairment.

- In patients with reduced urine output, crystalluria (crystals in urine) has been observed. Adequate fluid intake must be maintained to reduce this.

Broad-spectrum antibacterial medicine (effective against many types of bacteria and microbes).