Application Information

This drug has been submitted to the FDA under the reference 011721/001.

Names and composition

"NEPTAZANE" is the commercial name of a drug composed of METHAZOLAMIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
011721/001 NEPTAZANE METHAZOLAMIDE TABLET/ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
011721/002 NEPTAZANE METHAZOLAMIDE TABLET/ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
011721/001 NEPTAZANE METHAZOLAMIDE TABLET/ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
011721/002 NEPTAZANE METHAZOLAMIDE TABLET/ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
040001/001 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 25MG
040001/002 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 50MG
040011/001 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 25MG
040011/002 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 50MG
040036/001 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 25MG
040036/002 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 50MG
040062/001 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 25MG
040062/002 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 50MG
040102/001 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 25MG
040102/002 METHAZOLAMIDE METHAZOLAMIDE TABLET/ORAL 50MG

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Answered questions

Confused about pseudotumor cerebri?
Also, I wonder how reasonable it is when I'm having such severe headaches to go to the hospital asking for an LP (lumbar puncture aka spinal tap) Asked by Shelia Saysongkham 1 year ago.

When I get the severe headaches associated with pseudotumor cerebri, I literally feel like beating my head off the wall. I sometimes start pulling at my hair, and never does it get any more manageable. Lortab pain medication doesn't help, as I've had small prescriptions of them before after going to the hospital. I've gone to the ER a few times, but I just wonder if I really should keep going or not... I've seen a neurologist and have started taking Topamax about a week ago, but I'm not sure if it's helping yet. I mean I feel like I really need pain relief when it really hurts like that, but even worse I'm just worried cause sometimes my head will hurt for like 24+ hours and I'm not sure it it's ok to have intracranial pressure for that long, as I've heard it can cause deadly arterial pressure. But also, I think a dr should be checking the pressure levels at the points that it's killing me like that too you know? I'm just confused and while I know others have this condition, I feel so alone! lol Give me something good please! Even some info on the condition would be good. Also, if anyone knows if you have to have the shunt put in-how that affects pregnancy, if at all? I have one child already but we plan on more in the future. Answered by Darrick Toaston 1 year ago.

Although I have no idea some thing approximately your unique clinical situation, I have had a VP shunt for hydrocephalus practically when you consider that start. I have wanted surgical procedure to fix it, however that has no longer occurred very traditionally ago 37 years. Although I recollect the surgical procedure to fix or change the shunt to be principal mind surgical procedure, my neurosurgeons recollect it to be events. It simplest takes a few hours on the so much. However, as I stated, my shunt was once located to regard hydrocephalus, no longer your unique clinical situation. Any surgical procedure can also be horrifying, and all surgical procedure has a few danger. Talk along with your medical professionals and surgeons approximately your matters. If you're no longer convinced with their responses, uncover a further physician. It is regularly suitable to get a moment (and even 3rd or 4th) opinion. Answered by Maisha Nordling 1 year ago.


Any information about pseudo-tumor in your head? Does it ever go away on it's own? How to tell if it's present
Asked by Akilah Eperson 1 year ago.

When will this go away? It was thought in the past that pseudotumor was a self-limited disease that resolved over 1-2 years. While it is possible for pressures to vary over time, prolonged problems with CSF outflow may result in long-term increased pressure. The most common symptoms of high intracranial pressure are headache and visual loss. The headache may be located anywhere; frequently in the back of the neck. It is usually steady but may be pounding. It may be very severe, and unlike migraine, it may awaken the patient in the middle of the night. It also may worsen with bending or stooping. The optic nerve swelling may eventually lead to loss of vision seen as dimming, blurring or graying of vision. Patients may be aware of difficulty seeing to the side. Frequently patients notice visual disturbance lasting for a few seconds (often associated with bending or stooping). These visual "obscurations" may be very disturbing but do not increase the risk of visual loss. High pressure may cause damage to the nerves that move the eyes resulting in double vision. Patients may also be aware of a rushing noise in their ears. Nausea and vomiting may occur if the pressure is high and especially with a severe headache. Signs The most important clue to the presence of pseudotumor is the finding of disc swelling upon looking in the back of the eye. This is done after the pupil has been dilated. The disc swelling should be present in both eyes and is usually associated with retained central vision. Peripheral vision (detected on visual field testing) is usually abnormal and is one of the most important means of judging both the necessity for and effectiveness of treatment. The doctor will also want to check for asymmetric optic nerve involvement by looking at the swinging flashlight test. Eye movement problems may occur and be noted by the patient as double or blurred vision. Because tumors, abnormal connections between arteries and veins, and a clot in the veins of the head may produce similar signs and symptoms, the diagnosis of pseudotumor requires a normal MRI scan. The diagnosis also requires a spinal tap. This will document elevated pressure inside your head and make sure there are no other abnormalities in the CSF. The finding of abnormal cells, inflammatory cells, or elevated protein may indicate a previous infectious, inflammatory, or tumor related cause of elevated intracranial pressure. In rare cases, an angiogram, where a catheter is placed in the arteries and veins going to the head, may be necessary to exclude an abnormality of the blood vessels. Headache may persist in spite of treatment. Since headaches may be do to other causes it may be necessary to recheck intracranial pressure. A repeat spinal tap fail may indicate persistent pressure elevation. It is possible that pressure is only elevated transiently. In unusual circumstances a small pressure sensor may be inserted into the skull (requiring hospitalization) providing a continuous pressure read out over 1-2 days. Treatment Reduction in CSF production or increase in its outflow may reduce intracranial pressure. Weight reduction programs (in overweight patients) may be effective. If vitamin A is elevated its intake should be limited. Diamox (acetazolamide), a pill used for treating glaucoma, can lower pressure by reducing CSF production. It can cause side effects, including tingling of fingers and toes, loss of appetite, and intolerance of carbonated beverages. It may alter taste and causes frequent urination and fatigue. Much more rarely, it may predispose the patient to kidney stones or even cause bone marrow blood problems. Other agents similar to Diamox, such as Neptazane (methazolamide), may produce fewer side effects but may not be as effective. Diuretics, such as Lasix, may also be prescribed. Steroids (prednisone or dexamethasone) have been used to protect the optic nerve but have limited long term use and may produce significant side effects. Pressure may also be lowered by draining off CSF. This may be accomplished with a spinal tap but continuing production will replace the lost volume within hours. If too much fluid is drained the patient may suffer a low pressure or post spinal tap headache. Continuous drainage may be surgically accomplished by placing a catheter between the spinal canal and the abdomen (lumbo-peritoneal shunt). Potential problems include local back pain and future obstruction of the shunt leading to the need for further intervention. In patients with worsening visual fields or decrease in central acuity, who do not have severe headaches, an optic nerve sheath fenestration may protect the optic nerve from further damage. A small hole or multiple slits are placed in the optic nerve sheath just behind the eye using an operating microscope. Patients should be able to return home the same day. Complications include eye redness and double vision (which usually goes away). In rare cases vision may get worse. This procedure may not be successful in all cases and if the patient has persistent or recurrent vision problems, re-operation may be indicated. Over the counter pain medications may be partially effective in relieving headache but should not be over used as rebound worsening may occur. Medications used to treat migraine may also be effective. It is not rare for a migraine component to exist in a patient with pseudotumor. Thus correction of the increased CSF pressure may not relieve all headaches. Answered by Michelle Klette 1 year ago.

Pseudotumor cerebri (PTC) is encountered most frequently in young, overweight women between the ages of 20 and 45. Headache is the most common presenting complaint, occurring in more than 90 percent of cases. Dizziness, nausea, and vomiting may also be encountered, . Tinnitus, or a "rushing" sound in the ears, is another frequent complaint. While the mechanism of PTC is not fully understood, most experts agree that the disorder results from poor absorption of cerebrospinal fluid by the meninges surrounding the brain and spinal cord. The subsequent increase in extracerebral fluid volume leads to elevated intracranial pressure. However, because the process is slow and insidious, there is ample time for the ventricular system to compensate and this explains why there is no dilation of the cerebral ventricles in PTC. Many conditions and factors have been proposed as causative agents of PTC, including excessive dosages of some exogenously administered medications (e.g., vitamin A, tetracycline, minocycline, naladixic acid, corticosteroids), endocrinologic abnormalities, anemias, blood dyscrasias, and chronic respiratory insufficiency. However the majority of cases remain idiopathic in nature. All patients presenting with suspected papilledema or other manifestations of intracranial hypertension warrant prompt medical evaluation and neurologic testingoncluding imaging i.e. CT brain These tests are meant to rule out space-occupying intracranial mass lesion. Answered by Carmella Correra 1 year ago.

Having my photo taken in Trafalgar Square when I was 17, a pigeon landed on my head and started to coo and make advances to my beehive hairstyle. It didnt poo on me but it tried to mount my hair! Answered by Francie Mcrorie 1 year ago.


My left hand is moving without my control?
i am also having these problems in other parts of my body but my left hand is the main problem and it feels like i have some (but very little) control over it like if i focus really hard i can get it to stop but if i am just doing stuff it starts moving all over the place.... i have had the same problem with my... Asked by Hester Crossett 1 year ago.

i am also having these problems in other parts of my body but my left hand is the main problem and it feels like i have some (but very little) control over it like if i focus really hard i can get it to stop but if i am just doing stuff it starts moving all over the place.... i have had the same problem with my legs and other limbs and my head but mainly my left hand Answered by Ashlee Farrill 1 year ago.

See your health The medical term "essential" is often applied to conditions for which the cause is not known, and that unfortunately is the case with this troublesome neurological ailment. It sometimes runs in families, so there may be a genetic component. Unfortunately, there is no convincing evidence that any nutritional therapy will improve this trembling of the hands, face, or voice. Small quantities of alcohol may temporarily suppress it, and beta-blocker drug (such as propranolol or nadolol) frequently help. The anticonvulsant primidone (Mysoline) is also effective in some patients. In addition, one study with a small number of patients found about half responded well to a drug called methazolamide (Neptazane), also used for glaucoma. However, those medications help the tremor only as long as they're being used. It may be more helpful to minimize intake of substances that can worsen tremors, such as caffeine, certain drugs for asthma, and oral decongestants. And good luck. Answered by Katy Hongeva 1 year ago.

I'm left handed but I always wanted to be right handed since most things are set up for right handed people Answered by Mohamed Redhead 1 year ago.

This could be serious. See a doc Answered by German Rieper 1 year ago.


Confused about pseudotumor cerebri?
Also, I wonder how reasonable it is when I'm having such severe headaches to go to the hospital asking for an LP (lumbar puncture aka spinal tap) Asked by Tommie Alfisi 1 year ago.

When I get the severe headaches associated with pseudotumor cerebri, I literally feel like beating my head off the wall. I sometimes start pulling at my hair, and never does it get any more manageable. Lortab pain medication doesn't help, as I've had small prescriptions of them before after going to the hospital. I've gone to the ER a few times, but I just wonder if I really should keep going or not... I've seen a neurologist and have started taking Topamax about a week ago, but I'm not sure if it's helping yet. I mean I feel like I really need pain relief when it really hurts like that, but even worse I'm just worried cause sometimes my head will hurt for like 24+ hours and I'm not sure it it's ok to have intracranial pressure for that long, as I've heard it can cause deadly arterial pressure. But also, I think a dr should be checking the pressure levels at the points that it's killing me like that too you know? I'm just confused and while I know others have this condition, I feel so alone! lol Give me something good please! Even some info on the condition would be good. Also, if anyone knows if you have to have the shunt put in-how that affects pregnancy, if at all? I have one child already but we plan on more in the future. Answered by Kristen Pedro 1 year ago.

Although I have no idea some thing approximately your unique clinical situation, I have had a VP shunt for hydrocephalus practically when you consider that start. I have wanted surgical procedure to fix it, however that has no longer occurred very traditionally ago 37 years. Although I recollect the surgical procedure to fix or change the shunt to be principal mind surgical procedure, my neurosurgeons recollect it to be events. It simplest takes a few hours on the so much. However, as I stated, my shunt was once located to regard hydrocephalus, no longer your unique clinical situation. Any surgical procedure can also be horrifying, and all surgical procedure has a few danger. Talk along with your medical professionals and surgeons approximately your matters. If you're no longer convinced with their responses, uncover a further physician. It is regularly suitable to get a moment (and even 3rd or 4th) opinion. Answered by Emilie Guiltner 1 year ago.


Any information about pseudo-tumor in your head? Does it ever go away on it's own? How to tell if it's present
Asked by Constance Marshalek 1 year ago.

When will this go away? It was thought in the past that pseudotumor was a self-limited disease that resolved over 1-2 years. While it is possible for pressures to vary over time, prolonged problems with CSF outflow may result in long-term increased pressure. The most common symptoms of high intracranial pressure are headache and visual loss. The headache may be located anywhere; frequently in the back of the neck. It is usually steady but may be pounding. It may be very severe, and unlike migraine, it may awaken the patient in the middle of the night. It also may worsen with bending or stooping. The optic nerve swelling may eventually lead to loss of vision seen as dimming, blurring or graying of vision. Patients may be aware of difficulty seeing to the side. Frequently patients notice visual disturbance lasting for a few seconds (often associated with bending or stooping). These visual "obscurations" may be very disturbing but do not increase the risk of visual loss. High pressure may cause damage to the nerves that move the eyes resulting in double vision. Patients may also be aware of a rushing noise in their ears. Nausea and vomiting may occur if the pressure is high and especially with a severe headache. Signs The most important clue to the presence of pseudotumor is the finding of disc swelling upon looking in the back of the eye. This is done after the pupil has been dilated. The disc swelling should be present in both eyes and is usually associated with retained central vision. Peripheral vision (detected on visual field testing) is usually abnormal and is one of the most important means of judging both the necessity for and effectiveness of treatment. The doctor will also want to check for asymmetric optic nerve involvement by looking at the swinging flashlight test. Eye movement problems may occur and be noted by the patient as double or blurred vision. Because tumors, abnormal connections between arteries and veins, and a clot in the veins of the head may produce similar signs and symptoms, the diagnosis of pseudotumor requires a normal MRI scan. The diagnosis also requires a spinal tap. This will document elevated pressure inside your head and make sure there are no other abnormalities in the CSF. The finding of abnormal cells, inflammatory cells, or elevated protein may indicate a previous infectious, inflammatory, or tumor related cause of elevated intracranial pressure. In rare cases, an angiogram, where a catheter is placed in the arteries and veins going to the head, may be necessary to exclude an abnormality of the blood vessels. Headache may persist in spite of treatment. Since headaches may be do to other causes it may be necessary to recheck intracranial pressure. A repeat spinal tap fail may indicate persistent pressure elevation. It is possible that pressure is only elevated transiently. In unusual circumstances a small pressure sensor may be inserted into the skull (requiring hospitalization) providing a continuous pressure read out over 1-2 days. Treatment Reduction in CSF production or increase in its outflow may reduce intracranial pressure. Weight reduction programs (in overweight patients) may be effective. If vitamin A is elevated its intake should be limited. Diamox (acetazolamide), a pill used for treating glaucoma, can lower pressure by reducing CSF production. It can cause side effects, including tingling of fingers and toes, loss of appetite, and intolerance of carbonated beverages. It may alter taste and causes frequent urination and fatigue. Much more rarely, it may predispose the patient to kidney stones or even cause bone marrow blood problems. Other agents similar to Diamox, such as Neptazane (methazolamide), may produce fewer side effects but may not be as effective. Diuretics, such as Lasix, may also be prescribed. Steroids (prednisone or dexamethasone) have been used to protect the optic nerve but have limited long term use and may produce significant side effects. Pressure may also be lowered by draining off CSF. This may be accomplished with a spinal tap but continuing production will replace the lost volume within hours. If too much fluid is drained the patient may suffer a low pressure or post spinal tap headache. Continuous drainage may be surgically accomplished by placing a catheter between the spinal canal and the abdomen (lumbo-peritoneal shunt). Potential problems include local back pain and future obstruction of the shunt leading to the need for further intervention. In patients with worsening visual fields or decrease in central acuity, who do not have severe headaches, an optic nerve sheath fenestration may protect the optic nerve from further damage. A small hole or multiple slits are placed in the optic nerve sheath just behind the eye using an operating microscope. Patients should be able to return home the same day. Complications include eye redness and double vision (which usually goes away). In rare cases vision may get worse. This procedure may not be successful in all cases and if the patient has persistent or recurrent vision problems, re-operation may be indicated. Over the counter pain medications may be partially effective in relieving headache but should not be over used as rebound worsening may occur. Medications used to treat migraine may also be effective. It is not rare for a migraine component to exist in a patient with pseudotumor. Thus correction of the increased CSF pressure may not relieve all headaches. Answered by Sophie Schlotter 1 year ago.

Pseudotumor cerebri (PTC) is encountered most frequently in young, overweight women between the ages of 20 and 45. Headache is the most common presenting complaint, occurring in more than 90 percent of cases. Dizziness, nausea, and vomiting may also be encountered, . Tinnitus, or a "rushing" sound in the ears, is another frequent complaint. While the mechanism of PTC is not fully understood, most experts agree that the disorder results from poor absorption of cerebrospinal fluid by the meninges surrounding the brain and spinal cord. The subsequent increase in extracerebral fluid volume leads to elevated intracranial pressure. However, because the process is slow and insidious, there is ample time for the ventricular system to compensate and this explains why there is no dilation of the cerebral ventricles in PTC. Many conditions and factors have been proposed as causative agents of PTC, including excessive dosages of some exogenously administered medications (e.g., vitamin A, tetracycline, minocycline, naladixic acid, corticosteroids), endocrinologic abnormalities, anemias, blood dyscrasias, and chronic respiratory insufficiency. However the majority of cases remain idiopathic in nature. All patients presenting with suspected papilledema or other manifestations of intracranial hypertension warrant prompt medical evaluation and neurologic testingoncluding imaging i.e. CT brain These tests are meant to rule out space-occupying intracranial mass lesion. Answered by Fay Kubic 1 year ago.

Having my photo taken in Trafalgar Square when I was 17, a pigeon landed on my head and started to coo and make advances to my beehive hairstyle. It didnt poo on me but it tried to mount my hair! Answered by Floretta Sumners 1 year ago.


My left hand is moving without my control?
i am also having these problems in other parts of my body but my left hand is the main problem and it feels like i have some (but very little) control over it like if i focus really hard i can get it to stop but if i am just doing stuff it starts moving all over the place.... i have had the same problem with my... Asked by Ivory Niemela 1 year ago.

i am also having these problems in other parts of my body but my left hand is the main problem and it feels like i have some (but very little) control over it like if i focus really hard i can get it to stop but if i am just doing stuff it starts moving all over the place.... i have had the same problem with my legs and other limbs and my head but mainly my left hand Answered by Kenia Mikhaiel 1 year ago.

See your health The medical term "essential" is often applied to conditions for which the cause is not known, and that unfortunately is the case with this troublesome neurological ailment. It sometimes runs in families, so there may be a genetic component. Unfortunately, there is no convincing evidence that any nutritional therapy will improve this trembling of the hands, face, or voice. Small quantities of alcohol may temporarily suppress it, and beta-blocker drug (such as propranolol or nadolol) frequently help. The anticonvulsant primidone (Mysoline) is also effective in some patients. In addition, one study with a small number of patients found about half responded well to a drug called methazolamide (Neptazane), also used for glaucoma. However, those medications help the tremor only as long as they're being used. It may be more helpful to minimize intake of substances that can worsen tremors, such as caffeine, certain drugs for asthma, and oral decongestants. And good luck. Answered by Lowell Ujano 1 year ago.

I'm left handed but I always wanted to be right handed since most things are set up for right handed people Answered by Cristina Drossos 1 year ago.

This could be serious. See a doc Answered by Ona Jakovac 1 year ago.


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