Ibulam

GSL

For the relief of mild to moderate pain including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness and for the relief of the symptoms of cold and influenza.

For the relief of migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains.

Ibulam relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold and flu symptoms.

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • the common cold
  • toothache
  • muscular aches
  • backache
  • menstrual cramps
  • minor pain of arthritis
• temporarily reduces fever

Ibulam is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies.

In the treatment of non-articular rheumatic conditions, Ibulam is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low back pain; Ibulam can also be used in soft-tissue injuries such as sprains and strains.

Ibulam is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache including migraine headache.

Ibulam is indicated in adults and pediatric patients six months and older for the:

• management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics
• reduction of fever

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

Ibulam is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

For oral administration and short-term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults, the elderly, and children and adolescents over 12 years of age:

If in children and adolescents, between the age of 12 and 18 years, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

For adults aged 18 years or older the minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, or persist, the patient should consult a pharmacist or a doctor.

1 or 2 tablets to be taken up to three times a day, as required. The tablets should be taken with water.

Leave at least 4 hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period.

Not to be given to children under 12 years of age.

For oral administration and short-term use only.

During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.

Adults and children and adolescents between 12 and 18 years:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.

Children and Adolescents between 12 and 18 years: Take 1 or 2 caplets with water, up to three times a day as required.

Adults: Take 1 or 2 caplets with water, up to three times a day as required.

Leave at least four hours between doses.

Do not take more than 6 caplets in any 24 hour period.

Not for use by children under 12 years of age.

Directions

• do not take more than directed
• the smallest effective dose should be used
• adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
• children 12 years: ask a doctor

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults and children over 12 years of age: Two tablets taken as a single daily dose, preferably in the early evening well before retiring to bed. The tablets should be swallowed whole with plenty of fluid and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation. In severe or acute conditions, total daily dosage may be increased to three tablets in two divided doses.

Children: Not recommended for children under 12 years.

Elderly: The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic function is impaired, dosage should be assessed individually.

For oral administration. It is recommended that patients with sensitive stomachs take Brufen with food. If taken shortly after eating, the onset of action of Brufen may be delayed. To be taken preferably with or after food.

Important Dosage And Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Ibulam, the dose and frequency should be adjusted to suit an individual patient's needs. Do not exceed 3200 mg total daily dose in adults. Do not exceed 40 mg/kg or 2,400 mg, whichever is less, total daily dose in pediatric patients less than 17 years of age.

To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of Ibulam. Ibulam must be diluted prior to administration.

Dilute to a final concentration of 4 mg/mL or less. Appropriate diluents include 0.9% Sodium Chloride Injection USP (normal saline), 5% Dextrose Injection USP (D5W), or Lactated Ringers Solution.

• 100 mg dose: Dilute 1 mL of Ibulam in at least 100 mL of diluent
• 200 mg dose: Dilute 2 mL of Ibulam in at least 100 mL of diluent
• 400 mg dose: Dilute 4 mL of Ibulam in at least 100 mL of diluent
• 800 mg dose: Dilute 8 mL of Ibulam in at least 200 mL of diluent

For weight-based dosing at 10 mg/kg ensure that the concentration of Ibulam is 4 mg/mL or less.

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If visibly opaque particles, discoloration or other foreign particulates are observed, the solution should not be used.

Diluted solutions are stable for up to 24 hours at ambient temperature (approximately 20° C to 25° C) and room lighting.

Adults

For Analgesia (pain)

The dose is 400 mg to 800 mg intravenously every 6 hours as necessary. Infusion time must be at least 30 minutes. Maximum daily dose is 3,200 mg.

For Fever

The dose is 400 mg intravenously, followed by 400 mg every 4 to 6 hours or 100 mg to 200 mg every 4 hours as necessary. Infusion time must be at least 30 minutes. Maximum daily dose is 3,200 mg.

Pediatric Patients

For Analgesia (pain) And Fever

Ages 12 to 17 Years Of Age

The dose is 400 mg intravenously every 4 to 6 hours as necessary. Infusion time must be at least 10 minutes. Maximum daily dose is 2,400 mg.

Ages 6 Months To 12 Years Of Age

The dose is 10 mg/kg intravenously up to a maximum single dose of 400 mg every 4 to 6 hours as necessary. Infusion time must be at least 10 minutes. Maximum daily dose is 40 mg/kg or 2,400 mg, whichever is less.

Pediatric Dosing as Necessary for Fever and Pain

Treatment with Ibulam should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.

Posology

A course of therapy is defined as three intravenous injections of Ibulam given at 24-hour intervals. The first injection should be given after the first 6 hours of life.

The ibuprofen dose is adjusted to the body weight as follows:

- 1^st injection: 10 mg/kg,

- 2^nd and 3^rd injections: 5 mg/kg.

If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels.

If the ductus arteriosus does not close 48 hours after the last injection or if it re-opens, a second course of 3 doses, as above, may be given.

If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary.

Method of administration

For intravenous use only.

Ibulam should be administered as a short infusion over 15 minutes, preferably undiluted. If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection. Any unused portion of the solution should be discarded.

The total volume of solution injected should take into account the total daily fluid volume administered.

Recommended Dose

A course of therapy is three doses of Ibulam administered intravenously (administration via an umbilical arterial line has not been evaluated). An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Ibulam, no additional dosage should be given until laboratory studies indicate that renal function has returned to normal. If the ductus arteriosus closes or is significantly reduced in size after completion of the first course of Ibulam, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of Ibulam, alternative pharmacological therapy, or surgery may be necessary.

Directions For Use

For intravenous administration only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use Ibulam if particulate matter is observed.

After the first withdrawal from the vial, any solution remaining must be discarded because Ibulam contains no preservative.

For administration, Ibulam should be diluted to an appropriate volume with dextrose or saline. Ibulam should be prepared for infusion and administered within 30 minutes of preparation and infused continuously over a period of 15 minutes. The drug should be administered via the IV port that is nearest the insertion site. After the first withdrawal from the vial, any solution remaining must be discarded because Ibulam contains no preservative.

Since Ibulam is potentially irritating to tissues, it should be administered carefully to avoid extravasation.

Ibulam should not be simultaneously administered in the same intravenous line with Total Parenteral Nutrition (TPN). If necessary, TPN should be interrupted for a 15-minute period prior to and after drug administration. Line patency should be maintained by using dextrose or saline.