HIGHLIGHT
Astrofen

Astrofen

ibuprofen

Manufacturer:

Solvang

Distributor:

Nurturemed
Full Prescribing Info
Contents
Ibuprofen.
Description
Ibuprofen (Astrofen) is an orange-colored and orange-flavored suspension.
Each 5 mL (1 teaspoonful) contains: Ibuprofen, USP 100 mg.
Each 5 mL (1 teaspoonful) contains: Ibuprofen, USP 200 mg
Action
These products contain ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (also known as NSAIDs). Like other NSAIDs, ibuprofen works by changing the body's chemical response to pain, swelling, and fever resulting in relief of symptoms of inflammation (e.g., swelling, redness) and relief of pain and/or fever.
Indications/Uses
Ibuprofen is used in the management of mild to moderate pain and inflammation in conditions such as migraine, post operative pain, dental pain, musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis and rheumatoid arthritis including juvenile rheumatoid arthritis, peri-articular disorders such as bursitis and tenosynovitis and soft tissue disorders such as sprains and strains. It is also used to reduce fever.
Dosage/Direction for Use
Like other NSAIDs, the lowest effective dose of ibuprofen should be used for the shortest possible time.
These medicines are given orally.
Recommended oral dose in children: 5 to 10 mg/kg body weight per dose to be taken every 6 to 8 hours or as prescribed by the physician.
Ibuprofen (Astrofen) 100 mg/5 mL suspension: Pain and/or Fever: Children: 2-3 years: 1 teaspoonful (5 mL).
4-5 years: 1½ teaspoonfuls (7.5 mL).
6-8 years: 2 teaspoonfuls (10 mL).
9-10 years: 2½ teaspoonfuls (12.5 mL).
11 years: 3 teaspoonfuls (15 mL).
Ibuprofen (Astrofen) 200 mg /5 mL suspension: Children: 2-3 years: ½ teaspoon (2.5 mL).
4-10 years: 1 teaspoonful (5 mL).
11 years: 11/2 teaspoonfuls (7.5 mL).
Shake well before using.
Do not give more than directed.
Do not use more than 4 times a day.
Do not give longer than 10 days, unless directed by a doctor.
For patients with juvenile rheumatoid arthritis: The usual recommended dose is 7.5 to 12.5 mg/kg body weight per dose given every 6 hours. Consultation with a doctor is strongly recommended for patients with this condition.
Missed dose: If a dose is missed, give the next dose if still needed for pain and/or fever or inflammation and the subsequent dose every 6 to 8 hours thereafter.
Do not double the dose.
Overdosage
The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, fatigue (lethargy), and drowsiness. Other symptoms include headache, ringing in the ears (tinnitus), central nervous system depression, and convulsions. Excessive acidity of the blood (metabolic acidosis), coma, acute kidney failure, and absence of spontaneous breathing (apnea) may rarely occur.
What to do when the patient has taken more than the recommended dosage: If more than the recommended dosage has been given, consult a doctor or contact a Poison Control Center right away.
Contraindications
Do not give these medicines: If the child is allergic to ibuprofen, aspirin or other NSAIDs; right before or after heart surgery; if the child has a history of stroke, heart attack, uncontrolled high blood pressure, or congestive heart failure; if the child has advanced kidney or liver disease; if bronchospasm, angioedema, or nasal polyps are precipitated by ibuprofen, aspirin and other NSAIDs.
Special Precautions
Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include: Hives (elevated), whitish or reddish patches on the skin with severe itching or pricking sensations; shock (anaphylactic) (a hypersensitivity reaction resulting in generalized skin lesions and itchiness followed by low blood pressure and often accompanied by difficulty of breathing); facial swelling; skin reddening; asthma (wheezing); skin rash; skin blisters.
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning: These products contain an NSAID, which may cause severe stomach bleeding.
The chance is higher if the child; has had stomach ulcers or bleeding problems; takes a blood thinning (anticoagulant) or steroid medicine; take other medicines containing prescription or nonprescription NSAIDs (aspirin, naproxen, or others); takes more or for a longer time than directed.
If stomach upset occurs, take this medicine with food or milk.
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.
When using the product, the risk of heart attack or stroke may increase if the patient uses more than directed or for longer than directed.
Do not use after the expiry date on the label.
Ask a doctor before use if the child is: Having problems or serious side effects from taking pain relievers or fever reducers; taking any other medicine; under a doctor's care for any serious condition.
Ask a doctor before use if: Stomach bleeding warning applies to the child; child has a history of stomach problems, such as heartburn; child has not been drinking fluids; child has lost a lot of fluid due to vomiting or diarrhea; child has high blood pressure, heart disease, liver cirrhosis, or kidney disease; child is taking a medicine to help reduce the amount of water in the body (diuretic).
Stop use and ask a doctor if: Child experiences any of the following signs of stomach bleeding: Feels faint; vomits blood; has bloody or black stools; has stomach pain that does not get better.
Redness or swelling is present in the painful area.
Fever or pain gets worse or lasts more than 3 days; the child does not get any relief within the first day (24 hours) of treatment; any new symptoms appear.
Adverse Reactions
Undesirable effects from the use of ibuprofen are rare, but they may occur. Tell the doctor if the child experiences any undesirable effect.
The common undesirable effects of ibuprofen involve the stomach and intestine such as ulceration and/or bleeding; other undesirable effects are indigestion, heartburn, nausea, vomiting, eating disorder (anorexia), diarrhea, and constipation.
Other undesirable effects include dizziness, fatigue, headache, or nervousness. Increase or decrease in blood pressure may occur. Rashes or itch may also occur in some patients. Fluid retention may occur and, in some cases, edema develops.
Drug Interactions
When taken with blood thinning (anticoagulant) medicines (e.g., warfarin, dicumarol) or together with thrombolytic agents (e.g., streptokinase), ibuprofen may cause stomach and intestinal bleeding.
Aspirin decreases the amount of ibuprofen in the blood while salicylates and other NSAIDs (e.g., mefenamic acid, naproxen, diclofenac, ketoprofen, etc.) increase the risk of stomach and intestinal bleeding in patients receiving ibuprofen.
Ibuprofen increases the amount of lithium in the blood (increased risk toxicity) probably by reducing excretion of lithium.
Ibuprofen may cause acute reduction in kidney function and blood pressure response to ACE inhibitors (e.g., captopril, enalapril, ramipril, imidapril, fosinopril, lisinopril).
Ibuprofen may reduce the effect of diuretics such as furosemide and thiazide.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Astrofen oral susp 100 mg/5 mL
Packing/Price
(orange flavor) 60 mL x 1's
Form
Astrofen oral susp 200 mg/5 mL
Packing/Price
(orange flavor) 60 mL x 1's
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