A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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PENTASA® rectal suspensions are designed to provide the distal part of the intestinal tract with high concentrations of mesalazine and a low systemic absorption. Rectal suspensions have been shown to reach and cover the descending colon
Method of administration: 1. A visit to the toilet is recommended before administration of the rectal suspension. 2. Immediately before use take the rectal suspension bottle out of the aluminium foil pack and shake it well (Figure 1). 3. To break the seal twist the nozzle clockwise one full turn (the nozzle should then be in the same direction as before turning) (Figure 2). 4. Put your hand in one of the plastic disposal bags provided in the pack (Figure 3). 5. Hold the container as shown in the picture (Figure 4). Lubricate top part of rectal applicator. 6. To administer the rectal suspension, lie on your left side with the left leg straight and the right leg bent forward for balance. Carefully insert the applicator tip into the rectum. Maintain sufficient steady hand pressure while dispersing the bottle content. The bottle content should be applied within max. 30-40 seconds (Figure 5). 7. Once the bottle is empty, withdraw the tip with the bottle still compressed. 8. The rectal suspension should be retained in the bowel. Remain relaxed in the administration position for 5-10 minutes or until the urge to pass the rectal suspension has disappeared (Figure 6). Try to retain the rectal suspension overnight. 9. Roll the plastic disposal bag over the empty bottle (Figure 7). Discard it and wash your hands
Most patients who are intolerant or hypersensitive to sulphasalazine are able to take PENTASA® without risk of similar reactions. However, caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). In case of acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, therapy should be discontinued immediately. Caution is recommended in patients with impaired liver function. Liver function parameters like ALT or AST should be assessed prior to and during treatment, at the discretion of the treating physician. The drug is not recommended for use in patients with renal impairment. The renal function should be monitored regularly (e.g. serum creatinine), especially during the initial phase of treatment. Urinary status (dip sticks) should be determined prior to and during treatment at the discretion of the treating physician. Mesalazine induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment. The concurrent use of other known nephrotoxic agents should increase monitoring frequency of renal function. Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment. Please refer to section on Undesirable Effects Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely. Serious blood dyscrasias have been reported very rarely with mesalazine. Blood test for differential blood count is recommended prior to and during treatment, at the discretion of the treating physician. As stated in section Interaction with Other Medicinal Products and Other Forms of Interaction, concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine, or 6-mercaptopurine or thioguanine. Treatment should be discontinued on suspicion or evidence of these adverse reactions. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow-up tests should be carried out every three months. If additional symptoms occur, these tests should be performed immediately.