Gabazolamine-05

Gabazolamine-05 is used to relieve symptoms of anxiety caused by depression. It is also used to treat panic disorder in some patients.

Alprazolam is a benzodiazepine. Benzodiazepines belong to a group of medications called CNS depressants, which are medications that slow down the immune system.

This medication is only available with your doctor’s prescription.

This medication is available in the following forms:

• Tablet
• Disintegrating Tablet
• Solution
• Extended-Release Tablet

Before using Gabazolamine-05, you must know all about the risks and complications associated with it.

For this medication, there are many things that need to be considered:

• Allergies: Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.
• Geriatric: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population. Severe fatigue, dizziness, confusion, clumsiness or unsteadiness are more likely to occur in the elderly, who are normally more sensitive to the effects of this medication. Elderly patients may require a lower dose to help reduce unwanted effects.
• Pregnancy: This medication is listed as Pregnancy Category D. This means that studies in pregnant women have demonstrated a risk to the unborn child. However, the benefits of this medication in a life-threatening situation or serious disease may outweigh the potential risk.
• Breastfeeding: Studies have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medication.
• Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.

When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following
interactions were selected on the basis of potential significance and are not all-inclusive.

Using this medication with any of the following is not recommended.

Your doctor may decide not to treat you with this medication, or change some of the other medications you take:

• Delavirdine
• Flumazenil
• Indinavir
• Itraconazole
• Keoconazole

Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases.

Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

• Alfentanil
• Amobarbital
• Anileridine
• Boceprevir
• Bromazepam
• Buprenorphine
• Butabarbital
• Butalbital
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Ceritinib
• Chloral Hydrate
• Chlorzoxazone
• Clarithromycin
• Cobicistat
• Codeine
• Crizotinib
• Dabrafenib
• Dantrolene
• Dasabuvir
• Digoxin
• Domperidone
• Eliglustat
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fluconazole
• Fospropofol
• Hydrocodone
• Hydromorphone
• Idelalisib
• Levorphanol
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nilotinib
• Oxycodone
• Oxymorphone
• Pentobarbital
• Phenobarbital
• Piperaquine
• Primidone
• Propofol
• Propoxyphene
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Suvorexant
• Tapentadol
• Thiopental
• Voriconazole
• Zolpidem

Using this medication with any of the following medications may increase your risk of side effects. However, using both medications may be the best treatment for you.

If both medications are prescribed together, your doctor may change the dose or how often you take one or both medications:

• Amprenavir
• Cimetidine
• Desipramine
• Desogestrel
• Dienogest
• Drospirenone
• Erythromycin
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fluoxetine
• Imipramine
• Kava
• Levonorgestrel
• Mestranol
• Mifepristone
• Nefazodone
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Rifapentine
• Roxithromycin
• Sertraline
• St John's Wort
• Telaprevir
• Theophylline
• Troleandomycin

Other Interactions: Certain medications should not be used while eating, or while eating certain foods in the case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Using this medication with any of the following is not normally recommended, but may be unavoidable. If used together, your doctor may change the dose or how often you take your medication or give you special instructions about the use of food, alcohol or tobacco:

• Grapefruit Juice

Other Medical Problems: Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

• Depression
• Epilepsy or history of seizures
• Lung disease - Use with caution. May make these conditions worse.
• Glaucoma, acute narrow-angle - Should not be used in patients with this condition.
• Kidney disease
• Liver disease - Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Only use Gabazolamine-05 as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

Swallow the extended-release tablet whole with a glass of water. Do not break, crush or chew.

If you are using the orally disintegrating tablet, be sure your hands are drying before you handle the tablet. Do not remove the tablet from the bottle until you are ready to take it. Place the tablet on the top of the tongue. It should melt quickly and be swallowed.

If you are using the oral solution, measure the oral liquid with a marked measuring spoon, oral syringe or medication cup.

Dosing: Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For anxiety:

• Adults - Start with 0.25-0.5mg 3 times per day. Your doctor may increase your dose as needed. The dose is not normally more than 4mg per day.
• Older adults - Start with 0.25mg 2-3 times per day. Your doctor may increase your dose as needed.
• Children - Use and dose must be determined by your doctor.

For panic disorder:

• Extended release tablets:
• Adults - Start with 0.5-1mg 3 once per day in the morning. Your doctor may increase your dose as needed. The dose is not normally more than 10mg per day.
• Older adults - Start with 0.5mg once per day in the morning. Your doctor may increase your dose as needed.
• Children - Use and dose must be determined by your doctor.
• Solution, tablets, orally disintegrating tablets:
• Adults - Start with 0.5mg 3 times per day. Your doctor may increase your dose as needed. The dose is not normally more than 10mg per day.
• Older adults - Start with 0.25mg 2-3 times per day. Your doctor may increase your dose as needed.
• Children - Use and dose must be determined by your doctor.

Missed dose: If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Storage: It is very important to protect orally disintegrating tablets from moisture. Remove and throw away any cotton packaging from the bottle when first using this medication.

Store this medication in a closed container at room temperature. Keep it away from heat, moisture, and direct light. Do not freeze.

Keep our of the reach of children. Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

Before using Gabazolamine-05, there are some precautions you must take.

It is very important that your doctor checks in with you often while you are receiving this medication to make sure that it is working properly. Blood tests may be needed to check for any unwanted effects.

Do not take other prescription or over-the-counter medications without asking your doctor.

Using this medication while pregnant can harm your unborn child. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant, inform your doctor immediately.

Do not take itraconazole or ketoconazole while you use this medication. Using any of them together with this medication may increase the chance of serious side effects.

If you develop any strange and unusual thoughts or behaviours while taking this medication, be sure to inform your doctor. Some changes that occur in patients using this medication are like those seen in people who drink alcohol and then act in a way that is not normal.

Other changes may be more extreme, such as confusion, worsening depression, hallucinations (seeing, hearing or feeling things that are not there), suicidal thoughts and unusual excitement, nervousness or irritability.

This medication may cause some people to become drowsy, dizzy or less alert than normal. This is more likely to happen when you begin taking this medication, or when you increase the dosage.

Make sure you know how you react to this medication before driving, using machinery or doing anything else that could be dangerous if you are not alert.

Do not stop taking this medication without informing your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

This may help to prevent making your condition worse and to reduce the possibility of withdrawal symptoms, such as convulsions, stomach or muscle cramps, sweating, tremors, vomiting or unusual behaviour.

This medication may add to the effects of alcohol and other CNS depressants (medications that make your drowsy or less alert).

Some examples of CNS depressants are antihistamines or allergy medications, sedatives or sleeping medications, prescription pain medications or narcotics, medications for seizures or barbiturates, muscle relaxants or anaesthetics.

Inform your doctor if you are using any of the above while on this medication.

Gabazolamine-05 may produce unwanted side effects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

• Being forgetful (brain fog)
• Changes in patterns and rhythms of speech
• Clumsiness or unsteadiness
• Difficulty speaking
• Difficulty with coordination
• Discouragement
• Feeling sad or empty
• Irritability
• Lack of appetite
• Lightheadedness
• Loss of interest or pleasure
• Relaxed and calm
• Shakiness and unsteady walk
• Slurred speech
• Tiredness
• Trouble concentrating
• Trouble performing routine tasks
• Trouble sleeping (insomnia)
• Unsteadiness, trembling, or other problems with muscle control or coordination
• Unusual fatigue or weakness

Less common:

• Abdominal or stomach pain
• Blurred vision
• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles”, or tingling feelings
• Changes in behavior
• Chills
• Clay-colored stools
• Confusion about identity, place, and time
• Cough
• Dark urine
• Decrease in frequency of urination
• Decrease in urine volume
• Diarrhea
• Difficult or labored breathing
• Difficulty moving
• Difficulty passing urine (dribbling)
• Difficulty with concentration
• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• Dry mouth
• Ear congestion
• Environment seems unreal
• Fainting (syncope)
• Fear or nervousness
• Feeling of unreality
• Feeling warm
• Fever
• General feeling of discomfort or illness (malaise)
• Headache
• Hyperventilation
• Inability to move eyes
• Inability to sit still
• Increased blinking or spasms of the eyelid
• Irregular heartbeats (arrhythmias)
• Itching
• Joint pain
• Lack or loss of self-control
• Loss of bladder control
• Loss of coordination
• Loss of memory
• Loss of voice
• Mood or mental changes
• Muscle aching or cramping
• Muscle pain or stiffness
• Muscle weakness
• Nasal congestion
• Nausea
• Need to keep moving
• Painful urination
• Problems with memory
• Rash
• Restlessness
• Runny nose
• Seeing, hearing, or feeling things that are not there (hallucinations)
• Seizures
• Sense of detachment from self or body (depersonalization)
• Shaking
• Shivering
• Shortness of breath
• Sneezing
• Sore throat
• Sticking out of the tongue
• Sweating
• Swollen joints
• Talkativeness
• Tightness in the chest
• Trouble breathing, speaking or swallowing
• Trouble with balance
• Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• Uncontrolled twisting movements of the neck, trunk, arms, or legs
• Unpleasant breath odor
• Unusual drowsiness, dullness, fatigue, weakness, or feeling of sluggishness
• Unusual facial expressions
• Unusually deep sleep
• Unusually long duration of sleep (hypersomnia)
• Vomiting of blood
• Wheezing
• Yellow eyes or skin (jaundice)

Rare:

• Actions that are out of control
• Attack, assault, or force
• Chest pain
• Continuing ringing or buzzing or other unexplained noise in ears (tinnitus)
• Decreased awareness or responsiveness
• Deep or fast breathing with dizziness
• Ear pain
• False or unusual sense of well-being
• Fast, irregular, pounding, or racing heartbeat or pulse (tachycardia, arrhythmia, palpitations)
• Feeling jittery
• Feeling unusually cold
• Generalised slowing of mental and physical activity
• Hearing loss
• Hoarseness
• Lack of feeling or emotion
• Loss of control of the legs
• Loss of strength or energy
• Nightmares
• Numbness of the feet, hands, and around mouth
• Severe sleepiness
• Shakiness in the legs, arms, hands, or feet
• Sleep talking
• Sleeplessness
• Swelling
• Talking, feeling, and acting with excitement
• Thoughts of killing oneself (suicidal thoughts)
• Unable to sleep (insomnia)
• Uncaring
• Unusual weak feeling
• Voice changes

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More common:

• Absent, missed, or irregular menstrual periods
• Decreased appetite
• Decreased interest in sexual intercourse
• Decreased sexual performance or desire abnormal ejaculation
• Difficulty having a bowel movement (stool)
• Inability to have or keep an erection
• Increased appetite
• Increased in sexual ability, desire, drive, or performance
• Increased interest in sexual intercourse
• Increased weight
• Loss in sexual ability, desire, drive, or performance
• Stopping of menstrual bleeding
• Watering of mouth
• Weight loss

Less common:

• Abdominal bloating and cramping
• Blistering, crusting, irritation, itching, or reddening of the skin
• Change in taste bad unusual or unpleasant (after) taste
• Cracked, dry, or scaly skin
• Cramps
• Double vision
• Feeling of warmth
• Heavy bleeding
• Menstrual changes
• Pain
• Pelvic pain
• Redness of the face, neck, arms, and occasionally, upper chest
• Seeing double
• Sudden sweating
• Unexplained runny nose or sneezing

Rare:

• Acid or sour stomach
• Belching
• Bigger, dilated or enlarged pupils (black part of eye)
• Change in color vision
• Difficulty seeing at night
• Feeling of constant movement of self or surroundings
• Feeling of relaxation
• Heartburn
• Hives or welts
• Increased sensitivity of eyes to sunlight
• Indigestion
• Redness of skin
• Runny nose
• Sensation of spinning
• Stomach discomfort, upset, or pain
• Stuffy nose

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.