Oxybatin® For Patients

The recommended starting dose for adults is 4.5 g per day, given in two equal doses of 2.25 g per dose.

• Your doctor may gradually increase your dose up to a maximum of 9 g per day given in two equal doses of 4.5 g per dose. You take Oxybatin by mouth twice every night. The first dose is taken at bedtime and the second 2.5 to 4 hours later. You may need to use an alarm clock to make sure you wake up for the second dose.
• Food reduces the amount of Oxybatin® that is absorbed by the body. For this reason it is best to take Oxybatin® at regular times two to three hours after a meal.
• Prepare both doses before you go to bed.

Take the doses within 24 hours of preparation.

For people aged 7 years and older weighing 15 kg or more, the doctor will determine the correct dose based on your body weight.

• Your doctor will determine the correct dose for you. Do not exceed the dose that has been prescribed for you.

• If you have kidney problems, you should consider adopting a dietary recommendation to reduce your sodium intake. If you have liver problems, the starting dose should be halved. Your doctor may gradually increase your dose.

• • The instructions below explain how to prepare Oxybatin®. Read the instructions carefully and follow them step by step. Do not let children prepare Oxybatin®.
  • To help you, the box of Oxybatin® includes a bottle of medicine, a dosing syringe, a syringe/bottle adapter that fits onto the bottle and two dosing cups with a lid that children cannot remove.
  1. Remove the bottle cap by pressing it down while turning it to the left (anticlockwise). After removing the cap, place the bottle upright on a table. Holding the bottle upright, fit the adapter onto its neck by pressing it in. This only needs to be done the first time you open the bottle. The adapter will then stay on the bottle for all subsequent uses.
  2. Insert the tip of the dosing syringe into the central opening of the bottle adapter and push the syringe firmly down.
  3. Holding the bottle and the syringe with one hand, turn the bottle upside down and draw up the prescribed dose by pulling the plunger of the syringe upwards with the other hand. CAUTION: Liquid will not be drawn into the syringe unless you hold the bottle in an upright position.
  4. Return the bottle to an upright position. Remove the syringe from the central opening of the bottle adapter. Empty the medicine from the syringe into one of the dosing cups by pressing its plunger. Repeat this step for the second dosing cup. Then add about 60 ml of water to each dosing cup (60 ml is about 4 tablespoons).
  5. Place the special lid on each dosing cup by turning it to the right (clockwise) until you hear a click, an indication that the lid has locked into the safety position, which children cannot open. Wash the syringe with water.
  6. Before going to sleep:
  • Adult patients, place the second dose of the medicine near your bed.
  • The parent or caregiver of adolescents and children aged 7 years and older must not leave the second dose near the child’s bed or within close distance of the child.
  • You may need to set an alarm clock to wake up and take your second dose no earlier than 2.5 hours and no later than 4 hours after the first dose.
  • Then:
  • Remove the lid from the first dosing cup by pressing down and turning the lid to the left (anticlockwise).
  • Drink the whole amount of the first dose while sitting in bed, close the cup with the lid and lie down immediately afterwards. For children who sleep more than 8 hours but less than 12 hours, the first dose may be given after the child has slept for 1 to 2 hours.
  7. When you wake up or wake the child 2.5 to 4 hours later, remove the lid of the second dosing cup. While sitting in bed, drink the whole amount of the second dose and close the second cup with the lid, before lying down to continue your sleep.
  • If you have the impression that the effect of Oxybatin® is either too strong or too weak, tell your doctor or pharmacist.

The symptoms of overdose with Oxybatin® include agitation, confusion, movement disorder, breathing disorder, blurred vision, profuse sweating, headache, vomiting, impaired consciousness progressing to coma, and convulsions, excessive thirst, muscle cramps and weakness. If you take more Oxybatin® than recommended or if you take the medicine by mistake, seek urgent medical help. Take the medicine bottle with the label bearing the official markings with you, even if the bottle is empty.

If you forget to take the first dose, take it as soon as you remember and then continue taking the medicine as before. If you forget the second dose, skip it and do not take Oxybatin® again until the next night. Do not take a double dose to make up for the dose you forgot.

If you are in doubt about whether a dose was taken, do not take the dose again, to reduce the risk of overdose

Continue taking Oxybatin® for as long as your doctor recommends. You may find that cataplexy attacks return when you stop the medicine, and you may experience insomnia, headache, anxiety, dizziness, sleep disorders, somnolence, hallucinations and thought disorders.

If you have stopped the medicine for more than 14 consecutive days, consult your doctor, because treatment must be restarted with a reduced dose of the medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.