INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FASTWAY 120 (tablets)
FASTWAY 180 (tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FASTWAY 120 (tablets)
FASTWAY 180 (tablets)

COMPOSITION:
FASTWAY 120:
Each tablet contains 120 mg
fexofenadine hydrochloride
FASTWAY 180: Each tablet contains 180 mg fexofenadine hydrochloride

PHARMACOLOGICAL CLASSIFICATION
A 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION
Fexofenadine hydrochloride is a pharmacologically active metabolite of terfenadine and is a non-sedating, selective histamine H
1-receptor antagonist. Fexofenadine exhibits an antihistaminic effect beginning within one hour, achieving maximum effect at 6 hours and lasting 24 hours.
Pharmacokinetics
Fexofenadine is absorbed into the body following oral administration, with T
max occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/mL and 494 ng/mL following the administration of a 120 mg and 180 mg dose once daily, respectively. The volume of distribution is5,4-5,8 L/kg. Fexofenadine does not cross the blood brain barrier.
Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes negligible metabolism (about 5% of the total dose is metabolised, mostly by the intestinal mucosa, with only 0,5-1,5% of the dose undergoing hepatic biotransformation), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours, after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion (faeces), while up to 10% of the ingested dose is excreted unchanged through the urine.
Effect of age
In older subjects (>65 years old), peak plasma levels of fexofenadine were 99% greater than those observed in normal volunteers (<65 years old). Mean elimination half-lives were similar to those observed in normal volunteers.
Renal impairment
In patients with mild (creatinine clearance 41-80 mL/min) to severe (creatinine clearance 11-40 mL/min) renal impairment, peak plasma levels of fexofenadine were 87% and 111% greater, respectively, and mean elimination half-lives were 59% and 72% longer, respectively, than observed in normal volunteers. Peak plasma levels in patients on dialysis (creatinine clearance <10 mL/min) were 82% greater and half-life was 31% longer than observed in normal volunteers.

INDICATIONS
FASTWAY 120
is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR).
FASTWAY 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria (CIU).

CONTRA-INDICATIONS
Safety in pregnancy and lactation has not been established. (See “WARNINGS”).
The safety and efficacy of FASTWAY has not been studied in children under the age of 12 years.
Patients with known hypersensitivity to FASTWAY or any of its ingredients.

WARNINGS
There is only limited data for the use in elderly and renally or hepatically impaired patients. FASTWAY should be administered with care in these special risk groups.
FASTWAY has been detected in breast milk.
FASTWAY may affect the ability to drive or operate machinery.

INTERACTIONS
Interaction with other medicaments and other forms of interaction
FASTWAY
does not undergo hepatic biotransformation. Co-administration of FASTWAY with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of FASTWAY in plasma. The changes were not accompanied by any effects on the QT-interval and were not associated with any increase in adverse events compared to the drugs given individually.
The increase in plasma levels of FASTWAY observed after co-administration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.
No interaction between FASTWAYand omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to FASTWAY, causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of FASTWAYand aluminium and magnesium hydroxide
containing antacids.
PREGNANCY AND LACTATION
There is no experience with FASTWAY in pregnant women.
FASTWAY should not be taken during pregnancy or lactation.
DOSAGE AND DIRECTIONS FOR USE
Adults and children aged 12 years and over
Chronic idiopathic urticaria (CIU): One 180 mg tablet daily.
Seasonal allergic rhinitis (SAR): One 120 mg tablet daily.
Children under 12 years of age
The efficacy and safety of FASTWAY has not been studied in children under 12.
Special risk groups (See “WARNINGS”)
Based on increases of bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
Infections and infestations
Common: Viral infections such as cold or flu
Nervous system disorders
Common: Headache, drowsiness, dizziness
Common: Fatigue
Rare: Insomnia, nervousness, sleep disorders, paranoia
Respiratory, thoracic and mediastinal disorders
Common: Sinusitis
Gastrointestinal disorders
Common: Nausea, dyspepsia
Skin and subcutaneous tissue disorders
Rare: Rash, urticaria, pruritus
Reproductive system and breast disorders
Common: Dysmenorrhoea
Other
Rare: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis

Special Precautions
FASTWAY
lacks sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants. (See “Pharmacokinetics”, “INTERACTIONS”and “WARNINGS”).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Most reports of FASTWAY overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Standard measures should be considered to remove any unabsorbed drug. Haemodialysis does not effectively remove FASTWAY from blood.

IDENTIFICATION
FASTWAY 120:
Pink coloured, oval shaped, biconvex film coated tablets debossed with ‘FXF’on one side and ‘120’on other side
FASTWAY 180: Pink coloured, oval shaped, biconvex film coated tablets debossed with ‘FXF’on one side and ‘180’on other side

PRESENTATION
FASTWAY 120:
White opaque PVC/PE/PVDC blisters of 10 tablets are packed in to cartons of 10 or 30 tablets.
FASTWAY 180: White opaque PVC/PE/PVDC blisters of 10 tablets are packed in to cartons of 10 or 30 tablets.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light. Keep blisters in carton until required for use.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS
FASTWAY 120:
41/5.7.1/0319
FASTWAY 180: 41/5.7.1/0320

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE REGISTRATION CERTIFICATE
Dr. Reddy’s Laboratories SA (Pty) Limited
3rd Floor, TA Bank Building,
160 Jan Smuts Avenue,
Rosebank
2196 Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT
August 2007

New addition to this site: January 2008
Source: Pharmaceutical Industry

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